Regulatory Affairs Jobs at Amneal | Chemistry Graduates Apply Now
Are you looking for Regulatory Affairs Jobs with a global pharmaceutical leader? Amneal Careers offers an exciting opportunity for experienced professionals to join as a Manager, Regulatory Affairs – CMC in Ahmedabad, Gujarat. This role is ideal for candidates seeking long-term growth through high-impact regulatory strategy, FDA submissions, and cross-functional collaboration within one of the most trusted names in the pharmaceutical industry.
About Amneal
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
- Job Title: Manager, Regulatory Affairs
- Location: Ahmedabad City, Gujarat, India
- Job Category: Regulatory Affairs
- Apply Before: 01/30/2026, 11:12 AM
- Degree Level: Master’s Degree
- Job Schedule: Full-time
- Job Identifier: 6389
- Job Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, 380015, IN
Job Description
The Regulatory Affairs Manager CMC (Chemistry, Manufacturing & Controls), with minimal guidance, prepares (when required), reviews, and submits high-quality, regulatory submissions such as IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. The Manager, Regulatory Affairs – CMC is responsible for
developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products. Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage forms, including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in the US market, either for Aseptic sterilization or Terminal sterilization or both.Qualifications
- Taking the Lead in formulating the strategies for technical requirements or issues for complex sterile products and handling the projects with minimal supervision using the assigned resources.
- Having an in-depth knowledge and updates on FDA and ICH guidance, and knowing how to best implement the regulations for any given scenario.
- Compile, critically review, and submit IND, NDA, ANDA submissions and Amendments to the FDA with an overall objective to receive approval within the shortest timeframes possible.
- Must have thorough knowledge and expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs, either with Aseptic sterilization or Terminal sterilization or both techniques.
- Having prior knowledge of submitting the FDA correspondence, such as Pre-development/Pre-submission ANDA Meetings, Pre-IND, or Pre-NDA meeting requests.
- Administrative work, including maintaining full awareness of all regulatory activities on assigned projects, and ensuring that project deadlines and performance standards for these projects are established and met.
- Manage, interact, and train the given resources for quality submissions and newly published guidelines.
- Take the overall lead for assigned projects during product development to product approval, including communication with cross-function teams, discussing and concluding the review comments for quality submission documents.
- Ensure timely submission by implementing appropriate processes and coordination with inter- and intra-departments.
- Provide a regulatory strategy to the cross-functional team based on the FDA’s requirements and seek input from Team Leads when required.
- Evaluate change controls and formulate strategies for correct filing categories, with minimal involvement of a supervisor. Proactively raises major issues, if any, to the superior for resolution and agreement. Compile and submit critical post-approval supplements, such as CBE, CBE-30, and PAS.
- Prepare and finalize controlled correspondence as well as meeting packages to the FDA on specific issues as needed for assigned projects.
- Proactively raises major project issues to the superior for resolution and agreement.
- Be flexible in timings and available for t-cons as per the US team schedule.
Required Skills
- Regulatory Submission & Dossier Filing | Advanced
- Regulatory Guidelines Knowledge | Advanced
- Cross Functional Communication | Advanced
- Change Management & Documentation | Intermediate
- Problem Solving & Risk Mitigation | Intermediate
- Change Control & Regulatory Impact Assessment | Advanced
- Product Lifecycle Management | Advanced
- CMC Documentation | Advanced
- Health Authority Query Response | Advanced
- Regulatory Strategy Development | Advanced
About the Team
The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key roles that the Human Resources team performs:
- Executive Role: Specialists in all aspects of people management. High-level input at the strategic level into all key business decisions.
- Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
- Facilitator Role: Close partnership to support, advise, and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
- Consultancy Role: Provide expert advice to the organization and its managers on any aspect of workforce management and employee relations, and performance.
- Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
