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Regulatory Affairs Manager

  • LocationCorvallis, OR 97333 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:4 months ago
  • Job no: 42328
  • Category: Regulatory Affairs

Job Description

A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Regulatory Affairs Manager role. Our client, a leading pharmaceutical company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Responsibilities include:

1) Work closely with the Senior Director of Regulatory Affairs, Associate Director of Clinical Research 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 non-clinical or clinical submissions, while assisting with quality 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 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

If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply – we want to hear from you!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 04 Aug 2022, 12:40 PM