276 Financial Regulations jobs in India

**Responsibilities**:

- Preparation of dossiers as per the regulatory requirements of different countries, Dossier submission for ROW market
- Maintain the proper status of Registered and submitted dossier in respective countries
- Communication with the manufacturers to obtain the documents as per the regulatoryrequirements for import registration
- To solve the queries raised during registration followed by submissions of requested documents
- Communication with the manufacturers to obtain the documents as per the regulatoryrequirements
- To solve the queries raised during registration followed by submissions of requested documents
- FSSAI licensing submissions
- Documents preparations for import clearance of products
- Completion of documents for vendor approval system

**Qualifications**:
M.Sc, B. Pharm, M.Pharm

**Salary**: ₹300,000.00 - ₹350,000.00 per year

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Application Question(s):

- Let us know your current CTC, Expectation and Notice Period

**What you will do**
**Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.**
**Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.**
**Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.**
**Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.**
**Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.**
**Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.**
**Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.**
**Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.**
**Determining and communicating submission and approval requirements.**
**What you need:**
**Required-**
**Bachelor's or Master's degree in Regulatory Affairs, Engineering or equivalent discipline is required.**
**3 - 5 years experience**
**Preferred-**
**Experience with post-market and change management is a distinct advantage**
**RAC Certification is preferred**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Work Schedule**
Other
**Environmental Conditions**
Office
**Job Description**
**Responsibilities:**
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.
+ Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
+ Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
+ Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
+ Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
+ Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
+ Lead local performance evaluations, tests, and clinical studies to support product registration in India.
+ Participate in Animal Health regulatory submissions and support the distributed team as needed.
+ Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
+ Review advertisement materials for compliance with MD/IVD regulations in South Asia.
+ Analyze new and existing regulations, preparing impact assessments for LSG projects.
+ Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
+ Participate in regulatory/quality audits, exhibitions, and conferences.
+ Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
+ Perform other tasks as assigned by the line manager.
**Minimum Requirements:**
Education and Qualifications:
+ Bachelor's degree or higher in Engineering, Sciences, or Medicine.
+ Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.
**Essential Skills and Abilities:**
+ Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
+ Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
+ Strong planning and organizational skills for regulatory submissions and project management.
+ Excellent communication skills, including written, verbal, and presentation abilities.
+ Strong project management skills with the ability to lead regulatory projects.
+ Strong analytical skills, proactive, and a resourceful problem solver.
+ Ability to work effectively under pressure and manage flexible working hours.
+ Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
+ Experience in leading compliance activities, including post-market surveillance and advertisement review.
+ Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
+ Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

+ Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations.
+ Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations.
+ Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates.
+ Coordination of labeling related activities with cross functional teams for timely launch of products.
+ Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares.
+ Communication with third parties or private label distributors to gather needs and requirements of changes/labeling development.
+ Evaluation and coordinating with departments for REMS requirement for applications.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Key Accountabilities :**
Propose efficient regulatory pathway for New Product Introduction
? Develop & implement regulatory strategies for new/generic product registrations in
compliance with relevant regulations and the business needs
? Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.
related to new products filing
? Collaborate with other functions such as R&D, Quality, Supply chain, Project
Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with
business priorities
? Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to
CDSCO (Central Drugs Standard Control Organization), State FDA etc.
? Well versed with filing application of ND/SND/FDC/Import Registration/Import licence
etc on SUGAM portal
? Address queries from CDSCO/SFDA on submitted applications, provide regulatory
support for IPC/CDTL/CDL testing
? Manage submission of application dossiers with relevant regulatory authorities, monitor
the review process and take appropriate actions to obtain regulatory approvals as planned.
? Responsible for Subject expert committee (SEC) meetings including preparation of slide
deck in co-ordination with cross functional teams and SEC deliberation
Track all SEC meetings to identify and recommend new product ideas/opportunities
aligned with current business needs
? Provide Regulatory Support for timely new product launches
Minimum Education:
M. Pharm/B. Pharm
Minimum Experience Required:
8-10 years
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

**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.
**Job Summary:**
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation!
**Key Responsibilities:**
+ Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
+ Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
+ Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
+ Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
+ Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
+ Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
+ Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
+ Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.
**Basic Qualifications:**
+ 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 managing and leading a team in a regulatory or compliance environment
**Preferred Qualifications:**
+ Degree in life sciences, digital or data science, biochemistry, or chemistry
+ Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
+ Background or basic experience in digitalization, automation, software development
+ Background in manufacturing, process development, quality control, or quality assurance
+ Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
**What we expect from you**
We are all different, yet we all use our unique contributions to serve patients.
**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.
**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.