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Associate Director of Regulatory Affairs

  • LocationDanbury, CT 06810 - United States
  • Work TypeFull Time - Permanent
  • Positions1 Position
  • Published At:22 days ago


  • Job no: 37415
  • Categories: Regulatory Affairs

Job Description

Our client, a leading biopharmaceutical company, is currently recruiting an Associate Director of Regulatory Affairs who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:

1) Develop submissions for existing products, clinical programs and new product submissions

2) Develop a strategy for new pipeline combination products

3) Provide review and approval of product and process changes, as required, to ensure compliance with regulatory requirements

4) Assist in developing and documenting sound regulatory decisions and justifications and advising the organization on the impact of changing regulations

5) Interpret product, policy and process changes to ensure compliance with regulatory requirements

6) Review and approve product labeling and participate in design reviews to ensure adherence to regulatory requirements as set forth in the CFRs

7) Develop, implement and maintain procedures in support of regulatory compliance

8) Develop and manage TPPs for products, working with cross-functional disciplines

9) Assist with the development and implementation of regulatory labeling strategies for existing, new and modified products

10) Assist with the creation and maintenance of regulatory documents and claims, and up-to-date labeling for products

11) Provide regulatory guidance, respective to labeling, to product core teams developing new products

12) Work with Regulatory Leadership as company representatives with FDA, European Authorized Representative, and other regulatory agencies to obtain approvals

13) Interface with regulators through the submission process, through industry associations and other forums to ensure corporate awareness of critical path requirements

14) Develop regulatory plans including rationale and internal documentation for regulatory assessments

15) Participate in FDA meetings as necessary for pre-submissions, branch meetings, clinical studies INDs and promotional materials

16) Maintain awareness of competitive activities by monitoring major Medical meetings where assigned therapeutic area products are promoted

17) Monitor regulatory environment by reviewing regulatory and industry guidelines, untitled and warning letters to pharmaceutical companies and by attendance at major FDLI, DIA, and other industry meetings

18) Oversee and manage staff responsible for all operational processes and procedures related to the review and approval of materials with the purpose of promoting, advertising and providing information about the company and the company's products

19) Provide educational training for local regulatory staff, sales teams, contractors and others regarding company policies and procedures within the scope of the Regulatory Affairs

20) Assist with additional regulatory projects as needed

21) Perform other duties as assigned

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biopharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory affairs management

For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience


  • Published on 16 Apr 2021, 7:20 AM