43 Regulatory Affairs Manager jobs in Hyderabad

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities.

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities.
Key Activities
Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
+ Generate and execute of global and country-specific regulatory strategies
+ Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
+ Develop global dossiers for CMC content for initial submissions, variations and amendments
+ Support change management activities
+ Develop response strategy and respond to health authority questions
+ Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
+ Liaise with local regulatory teams to align on filing strategy
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
+ Follow established department regulatory processes to ensure cross-product alignment
Knowledge and Skills
CMC- specific regulatory knowledge & experience
Education & Experience (Basic)
Doctorate degree
OR
Master's degree and 3 years of directly related experience
OR
Bachelor's degree and 5 years of directly related experience
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India. The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries.
The team member will be responsible for maintaining U.S. state and federal commercial product licenses and will collaborate with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams on strategies and activities impacting licensed products.
**Roles & Responsibilities:**
Key responsibilities of the Regulatory Affairs Manager include:
+ Conducts periodic assessments of licenses / facilities andensures business practices comply with current regulations and statutes.
+ Evaluates new and existing regulations to maintain up-to-date compliance.
+ Communicatesrequirements to internal Amgen functional teams.
+ Obtains supplemental documentation from internal and external partners.
+ Prepares, reviews, and submits license applications and renewals.
+ Maintains all State Licensing documentation, submissions, and interactions with State Authorities.
+ Interfaceswith State Board of Pharmacy (BoP) and/or Department of Health (DoH).
+ Completes required annual notifications to U.S. FDA
+ Obtains DUNS and FEI numbers for new U.S. sites, as required
+ Processes Financial obligations relating to fee payment.
+ Identifies and implements process improvements for the state licensing process
+ Coaches and supports junior regulatory staff's career development
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The successful candidate will have the following qualifications:
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
+ Bachelor's degree and 5 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
**Preferred Qualifications:**
+ Degree in Life Science discipline
+ Regulatory CMC specific knowledge & experience
+ Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
+ Working knowledge of US state and/or federal licensing requirements
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities.
Key Activities
Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
+ Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development,
+ Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally
+ Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation
+ Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff
+ Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
+ Develop response strategy and respond to health authority questions
+ Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
+ Liaise with local regulatory teams to align on filing strategy
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
+ Follow established department regulatory processes to ensure cross-product alignment
Knowledge and Skills
Regulatory CMC- specific regulatory knowledge & experience
Staff management and development
Education & Experience (Basic)
Doctorate degree
OR
Master's degree and 3 years of directly related experience
OR
Bachelor's degree and 5 years of directly related experience
OR
Associate's degree and10 years of directly related experience
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
+ Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Support trend analysis and continuous improvement initiatives
+ Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
+ Working experience with disclosures on public registries e.g. ClinicalTrials.gov
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Good communication skills including excellent spoken and written English
+ Ability to follow controlled processes
+ Leadership skills, including ability to teach, negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
**Basic Qualifications:**
+ Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
OR
+ Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry
+ Minimum of 2 years experience in preparation of regulatory documents for public disclosure
+ Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will report to the Amgen India R&D Finance lead. The R&D Finance Associate will assist in planning, quarter close and consolidation activities. The candidate is also expected to expand the centralization, automation and standardization practices established in R&D Finance team.
+ FP&A professional skilled in comprehensive financial data management, financial analysis and forecasting, ad hoc project financial support, and process optimization.
+ Support functional and consolidation teams in R&D finance
+ Master Data Maintenance including but not limited to managing and updating financial master data across all systems to ensure accuracy and integrity, cost center creation, modification, and deactivation, aligning them with the organizational structure, creation of Work Breakdown Structures (WBS) for precise project tracking and financial reporting.
+ Provide headcount and staffing support by maintaining relevant data and assisting in workforce planning. Support efficient data migration from the business planning tool to financial system
+ FE&O and Staff Support planning and Variance Analysis: Conduct variance analysis to identify trends and discrepancies between actuals and forecasts. Forecasting of certain trended/low risk planning accounts
+ Product Coding and Recovery Optimization: Support product coding processes and recovery methods to improve financial accuracy and efficiency.
+ Handle Ad hoc requests: Providing accurate and timely support to stakeholders.
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications:**
Master's degree and 0 to 2 years of accounting and/or finance (OR)
Bachelor's degree and 0 to 2 years accounting and/or finance (OR)
**Preferred Qualifications:**
Pharmaceutical / biotechnology industry experience
Knowledge and understanding of financial planning processes, quarter close activities
Strong analytical skills and exceptional attention to detail
Excellent discernment (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas)
**Good To Have Skills**
Big 4 and Fortune 500 FP&A experience
Capable of building models and financial reports
Technical finance knowledge and skills (accounting, planning, modeling, etc.)
Overall knowledge of financial systems and tools (e.g., SAP, Hyperion, Anaplan, Excel)
Business partnering skills. Ability to work effectively in ambiguous situations and team environment
**Soft Skills:**
Effective analytical and communication skills (both verbal and written)
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Collaborative, with a focus on achieving team goals
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Managing regulatory affairs of the organization its subsidiaries/associates Liaising

with regulatory bodies like State and Central FDA,DCI Well conversant with Drug

law/feed supplement regulation Co-ordination with purchase, marketing departments

Preparation of Applicant part and Restricted part DMFs (USDMF, EUDMF and ROW).

**Salary**: From ₹171,172.50 per year

**Benefits**:

- Health insurance
- Internet reimbursement
- Leave encashment
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (required)

**Manager - International Regulatory Lead**
**Role Name: Manager - International Regulatory Lead (IRL)**
**Department Name: International Regulatory Team, Global Regulatory Affairs**
**Role GCF: 5A**
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
Role Description
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
- optimize product development and regulatory approvals in International countries
- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
- Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
- Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
- Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
- Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
- Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
- Partners with peers to agree on product strategy including projected submission and approval time.
- Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.
- Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
- Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
**Basic Qualifications and Experience**
· Doctorate degree OR
· Master's degree and 3 years of relevant regional regulatory experience OR
· Bachelor's degree and 5 years of relevant regional regulatory experience OR
· Associate degree and 10 years of relevant regional regulatory experience OR
· High school diploma/GED and 12 years of relevant regional regulatory experience.
**Functional Skills**
Must-Have Skills
- Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
- Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
- General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
Good-to-Have Skills
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across country, regional and international borders.
Soft Skills
- Strong communication skills, both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to work effectively with global, local and virtual teams
- High degree of initiative and self-motivation
- Planning and organizing abilities
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Good negotiation and influencing skills.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
In this essential role, you will oversee the coordination and execution of FDA 2253 reporting submissions, while also serving as Amgen's Digital Asset Management (DAM) librarian. In addition, this role will provide comprehensive administrative support to Operations staff throughout project lifecycles such as label changes. As a cross-functional position, you will collaborate closely with Regulatory Operations, engage with marketing teams as well as creative agencies to drive key commercial objectives. A strong proficiency in graphic design and video editing software-such as Adobe Creative Suite, Premiere Pro, and After Effects-is critical for success in this role. Additionally, proficiency with Veeva Promomats is highly preferred.
**Roles and Responsibilities:**
+ Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
+ Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
+ Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials.
+ Leverage company subscriptions to provide art procurement services in support of Amgen's marketing initiatives.
+ Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen's various data repositories.
+ Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management (DAM) timelines and processes.
+ Maintain and manage records in Veeva Promomats, RIM and SharePoint; prior experience with SharePoint and Veeva Business Admin certification preferred.
+ Lead and facilitate Webex/MS Teams meetings, including agenda preparation and accurate documentation of meeting minutes.
+ Create infographics and presentation materials; perform technical editing and proofreading of process documentation.
**Required Knowledge and Skills:**
+ Veeva PromoMats and RIM experience.
+ Proficiency in Veeva PromoMats and RIM with hands-on experience navigating the platform to manage promotional and medical content.
+ Strong understanding of Veeva workflows, including initiating, reviewing, approving, and routing materials through the appropriate lifecycle stages.
+ Experience performing quality control (QC) checks on submitted materials to ensure compliance with US regulatory, legal, and brand standards.
+ Ability to update and maintain metadata accurately within Veeva PromoMats and RIM, ensuring consistency with naming conventions, taxonomy, and version control requirements.
+ Proficiency in Veeva digital asset management (DAM) systems and experience handling various file types, metadata, licensing agreements, and usage rights.
+ Familiarity with digital asset management (DAM) best practices, including asset tagging, archiving, and retrieval within Veeva, SharePoint, and BOX.
+ Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical or life sciences industry.
+ Experience troubleshooting and resolving metadata or workflow issues, including collaboration with cross-functional teams (e.g., Regulatory, Marketing, or Creative Agencies).
+ Detail-oriented mindset with the ability to identify discrepancies and ensure data integrity across documents and metadata fields.
+ Comfortable working in a fast-paced, highly regulated environment, managing multiple tasks and priorities within tight deadlines.
+ Strong communication skills to effectively liaise with stakeholders and provide guidance on Amgen's Veeva PromoMats processes and best practices.
+ Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions with a strong knowledge of US FDA eCTD publishing tools
+ Has knowledge of the US FDA guidance for submissions of promotional materials.
+ Strong knowledge of Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other design tools.
+ Proficient in Microsoft Office Suite, including PowerPoint, Visio, Excel (with pivot tables), and Word.
+ Proven ability to manage multiple projects simultaneously while meeting deadlines and adhering to established processes.
+ MS Outlook inbox management, including organizational skills, creating email rules, and standard email templates.
+ Develop and maintain clear, structured process documents, SOPs, and workflow guides.
+ Design and run periodic and ad hoc reports using Veeva's reporting functionality to support leadership in the analysis and interpretation of performance data.
**Preferred Knowledge and Skills:**
+ Bachelor's degree in graphic design, visual arts, marketing, or a related creative field.
+ Minimum of +2 years of experience in marketing, pharmaceutical, or healthcare industries, with a strong understanding of regulatory requirements for promotional materials.
+ Veeva Business Admin certification.
+ Experience collaborating with creative agencies and cross-functional teams to facilitate the collection, transfer and distribution of marketing materials.
+ Excellent attention to detail and ability to conduct thorough quality control checks on creative files for promotional content.
+ Understanding FDA regulations and compliance requirements related to marketing materials and submissions.
+ Strong analytical and problem-solving skills to ensure accuracy in digital asset retrieval, troubleshooting of file issues, validation, and distribution.
+ Effective communication and stakeholder management skills to lead and participate in discussions regarding DAM timelines and creative file submission approvals.
**AIN working hours for this position:**
This position supports the Regulatory Promotion and Material Compliance activities serving Amgen's US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.
**EQUAL OPPORTUNITY STATEMENT**
+ Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
+ We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.