Nivagen Pharmaceuticals - Deputy General Manager/General Manager - Regulatory Affairs Department

Deputy General Manager/General Manager - Regulatory Affairs Department

Job Description :

1. Plans and compiles high quality US regulatory submissions for generic drug products to expedite clearance/approval and sustain commercial availability for all products.

2. Supervise regulatory document assembly, review, and submission (i.e. ANDAs in eCTD format, amendments, supplements, annual reports etc) to FDA, while ensuring that the compilation and transmittal of regulatory submissions are completed within defined time schedules and meet established standard and applicable regulations and FDA guidance.

3. Interact with regulatory agencies as required in a timely and appropriate manner to respond to any questions during the review process.

4. Participate and represent Regulatory in meetings and interact with members of all development project teams to convey regulatory requirements and develop a strategy to meet divisional goals.

5. Communicate regulatory issues to functional areas and transmit regulatory concerns from functional areas to Regulatory Affairs senior management.

6. Interacts with the FDA to facilitate approval of the regulatory submissions

7. Review and approve change controls for potential impact on regulatory status.

8. Prepare submissions, supplements, amendments, and letters to file as needed to document rationale. Keep correspondence history file current.

9. Demonstrate leadership on the team and within the function to accomplish objectives.

10. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.

11. Review and approve labeling, promotional literature and other documents for regulatory compliance.

12. Prepare and submit to adverse drug experience report to FDA.

13. Review and approve annual reports for approved drug products. To overview that annual reports are submitted to the agency (FDA) in a timely and efficient manner.

14. Coordinate and document recalls or other RA related field actions. Report and update appropriate regulatory bodies as needed.

15. Maintain well-organized RA life cycle projects records that allow ready retrieval of required information.

16. Responds to product information requests. Researches and collects information and data to support periodic reports to regulatory agencies.

17. Provides Regulatory Affairs support during internal and external audits.

18. Assists in the development of best practices for Regulatory Affairs processes.

19. Represents Regulatory Affairs on cross-functional project teams.

20. Responsible for managing multiple projects ranging in responsibility across the regulatory affairs department.

21. Experience in cGMP pharmaceutical R&D and / or Manufacturing Operations a plus.

22. Experience with working with third party CMOs on development and product manufacturing and launches.

23. Experience with ANDA drug development.

Candidate Profile :

1. Minimum of 12 years experience in the generics pharmaceutical industry, with at least 4 years in Management experience

2. Strong analytical skills and business acumen specific to operational activities and product launches in generics.

3. Cross functional collaboration skills with the ability to network with different functional areas and integrate cross functional deliverables.

4. Sterile injectable and Solid Oral Dosage form registration experience candidates are required

5. Proficiency in MS Office, MS Project, and SharePoint.

6. Strong oral interpersonal and written communications skills.