Amneal Pharmaceuticals - Manager - Regulatory Affairs

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 form including Sterile, Sterile (Injectables / Ophthalmic / Otic / IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or - Taking 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 abreast knowledge and updates on FDA and ICH guidance and should know how to best implement the regulations for any given scenario.
• Compile, critically review and submit IND, NDA, ANDA submissions and Amendments to 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 on submitting the FDA correspondences such as Pre-development / Pre-submission ANDA Meetings, Pre-IND or Pre-NDA meeting request.
• Administrative work including maintaining full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
• Manage, Interact, Train the given resources for quality submissions and newly published guidances.
• 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.

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 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 Roles That The Human Resources Team Performs

best practice employment policies and procedures.

Performance Management, Health and Wellbeing.

developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

(ref : iimjobs.com)