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Associate Director of Regulatory Affairs

  • LocationCorvallis, OR 97333 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:4 days ago
  • Job no: 42327
  • Category: Regulatory Affairs

Job Description

Our client, a leading pharmaceutical 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) Work closely with the CMC and Regulatory Affairs team and other project team members in determining and preparing global regulatory strategies for the development and approval of products

2) Provide input on regulatory issues relating to developmental and post-marketing conditions

3) Plan and coordinate documentation and data for regulatory with a primary focus on chemistry, manufacturing and control submissions

4) Prepare submissions of registration documents

5) Review material for completeness, internal consistency with other documents and conformance to applicable agency regulations

6) Ensure the readiness for submission by gathering missing information and resolve internal consistency and regulatory issues

7) Compile high-quality submissions that meet all applicable regulatory requirements.

8) Provide regulatory input and advice on the creation, implementation and revision of SOPs

9) Keep abreast of the current regulatory environment in the other applicable markets

10) 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 pharmaceutical 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 04 Aug 2022, 12:42 PM