Explore regulatory affairs job opportunities in 77 Regulatory Affairs jobs in Hyderabad
Regulatory Affairs
Posted today
Job Viewed
Job Description
Role & responsibilities
CMC and Labelling:
- Preparation of ANDAs in eCTD format for various type of formulations
- Review of the technical documents such as Specifications, BMR, MFC,
- Able to work on All type of CTD section write-ups
- Hands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS)
- Through knowledge on ICH guidances
- Should able to handle Module -I related activities
- Able to review Drug substance DMF and should prepare a due diligence
eCTD Related activities:
Complete knowledge on eCTD related publishing activities
Practical knowledge on PDF attributes such as book marking, intra inter hyper ink, file destination TOC's etc., should adhere to FDA published latest guidance
- Creation of eCTD sequence
- File names per requirement
- Uploading the documents for new sequence and knowledge on Append, add replace attributes for LCM products
- External hyperlinking from the server
- Should able to handle the errors that encounters during publishing
- Practical knowledge on inbuilt and other approved validator (Lorenz )
Preferred candidate profile
Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada
Perks and benefits
Regulatory Affairs
Posted today
Job Viewed
Job Description
We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad Location
The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions.
Required Candidate profile
B.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are Eligible to Apply
Regulatory Affairs Analyst
Posted today
Job Viewed
Job Description
Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because
Good Health Can't Wait
.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
'The Next and the New' is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
Job Description
We are looking for a Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals.
This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP. Collaboration with European Regulatory authorities and internal teams will be essential to ensure the regulatory compliance for new applications.
Roles & Responsibilities
- Should have an regulatory experience in Europe market new application submissions
- Preparation, review and submission of new applications through DCP, MRP, NP for EU.
- You will be responsible for preparation and review of m1 documentation in-line to the m2-5 documents.
- You will be responsible for preparation of product information and review of artworks to ensure regulatory compliance.
- Direct Interaction with EU regulatory authorities.
- Handling of deficiencies and timely response to regulatory agencies
- Good interpersonal skills with command on English language to communicate with Regulatory agencies & IL Customers
- Providing regulatory guidance/regulatory strategies to IL partner and other cross functional teams
- Support the manufacturing sites during Regulatory audits
- You will be responsible for performing other tasks and duties assigned by the immediate supervisor.
- You will be responsible for preparation of artworks, including product information to ensure regulatory compliance.
- You will be responsible for delivering registration goals with minimum supervision.
- You will be responsible for monitoring and follow-up of product filings for early approval of applications with regulatory authorities.
- You will be responsible for participating in the industry association to keep abreast of regulations.
- You will be responsible for creation and revision of new or existing SOPs (Standard Operating Procedures).
- You will be responsible for developing and maintaining a good relationship with the Europe health authorities.
- You will be responsible for performing other tasks and duties assigned by the immediate supervisor.
Qualifications
Educational qualification:
M.SC or M.pharm
Minimum work experience:
8 to 12 years of experience in regulatory affairs preferably in Europe registrations (Including M1)
Skills & attributes:
- Knowledge of EMA guidelines.
- Proficiency in spoken and written English.
- Proficiency in using a computer and its applications, specifically Google Applications and MS Excel.
- Excellent interpersonal and communication skills.
- Attention to detail and the ability to multi-task and meet strict deadlines.
Additional Information
About the Department
Integrated Product Development Organisation
We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.
Benefits Offered
At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website
Regulatory Affairs Specialist
Posted 2 days ago
Job Viewed
Job Description
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
+ Monitors and improves tracking / control systems.
+ Keeps abreast of regulatory procedures and changes.
+ May direct interaction with regulatory agencies on defined matters.
+ Recommends strategies for earliest possible approvals of clinical trials applications.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 1 year of relevant experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
Associate Regulatory Affairs
Posted 2 days ago
Job Viewed
Job Description
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.
Regulatory Affairs Manager
Posted today
Job Viewed
Job Description
- 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
Analyst Regulatory Affairs
Posted today
Job Viewed
Job Description
Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because
Good Health Can't Wait
.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
'The Next and the New' is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
Job Description
Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines.
Qualifications
M. Pharm, M.Sc OR PhD
Additional Information
Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.
Be The First To Know
About the latest Regulatory affairs Jobs in Hyderabad !
Regulatory Affairs Manager
Posted today
Job Viewed
Job Description
Job Summary:
The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India).
Key Responsibilities:
Regulatory Strategy & Compliance.
- Develop and implement regulatory strategies for product launches and market expansions.
- Ensure the certifications are renewed on time and also apply for new certifications in new geographies.
- Interpret and apply country-specific regulations (FDA/DSHEA, EFSA, FSSAI, etc.) to ensure compliance.
Dossier & Documentation Management.
- Prepare and maintain regulatory submissions, including product dossiers, GRAS documentation, and ingredient justifications.
- Ensure technical files and records (safety data, clinical support for claims, specifications) are audit-ready.
Labelling, Claims & Marketing Review.
- Review and approve labels, packaging, and marketing materials for regulatory compliance.
- Evaluate substantiation for health and structure/function claims to ensure legal acceptability.
Cross-functional Collaboration
- Collaborate with R&D, Quality, Marketing, and Legal teams to align product development with regulatory requirements.
- Provide regulatory support during product lifecycle management and reformulations.
Regulatory Liaison
- Act as the point of contact with national and international regulatory agencies (e.g., FDA, EFSA, FSSAI, TGA).
- Lead the response to agency inquiries, inspections, or compliance reviews.
Training & Risk Management
- Provide internal training on new regulations and compliance procedures.
- Identify and mitigate regulatory risks associated with ingredients, claims, or labelling.
Required Qualifications:
- Bachelor's or Master's degree in Pharmacy, Food Science, Chemistry, Life Sciences, or a related discipline.
- 5+ years of experience in regulatory affairs in the nutraceutical, dietary supplement, or functional foods sector.
- Strong knowledge of international regulatory frameworks: FDA/DSHEA (U.S.), EFSA (EU), FSSAI (India).
- Familiarity with Codex Alimentarius and GMP guidelines preferred.
- Excellent written and verbal communication skills.
- Attention to detail and experience handling complex documentation.
Preferred Experience:
- Experience with digital regulatory platforms or document management systems.
- Experience interacting directly with regulatory authorities or participating in audits/inspections.
- Regulatory submissions for new ingredients, import/export regulatory support.
Manager Regulatory Affairs
Posted today
Job Viewed
Job Description
Regulatory Liaison: Sound knowledge of schedule-M and all approval required for API and CDMO organisation. Act as the main interface with CDSCO, DCA, and other regulatory state authorities. Oversee applications (all types CT-11, 15, Form-25, 29, WC)
Regulatory Affairs CMC
Posted today
Job Viewed
Job Description
Role & responsibilities
- Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers.
- Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response.
- Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines.
- Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports,
- Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages.
- Formulate US regulatory filing strategy for new projects.
- Preparing quarterly and monthly targets. Allotting and evaluating targets of the team.
Good interpretation skill for ICH and FDA guidelines