Manager, Regulatory Affairs

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 both.

• 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.
• Ensure timely submission by implementing appropriate process and co-ordination with inter and intra departments.
• Provide a regulatory strategy to Cross-function team based on FDA’s requirement and seek input from Team Leads, when required.
• Evaluate change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Proactively raises major issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS.
• Prepare and finalize controlled correspondence as well as meeting package to FDA on specific issues as needed for assigned projects.
• Proactively raises major project issues to superior for resolution and agreement.
• Be flexible in timings and available for t-cons as per 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