Associate Director of Regulatory Affairs - Rochester, United States - Sterling Life Sciences

Description

Job Description

Our client, a leading biotechnology 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) Provide regulatory guidance and strategy for gene therapy programs, including assessing and identifying regulatory risks

2) Manage activities with emphasis on regulatory strategy preparation, review and submission of documents for FDA and other regulatory authorities

3) Review and provide input on all regulatory filing documents

4) Lead and facilitate activities, including team preparation, for meetings with FDA and other regulatory authorities for development activities

5) Be responsible for communicating with FDA and other regulatory authorities

6) Identify issues and develop appropriate regulatory strategies to mitigate risks to filings

7) Ensure stakeholders are informed of developments that may affect regulatory success

8) Perform compliance functions within the company

9) Coordinate and manage regulatory inspections, as needed

10) Stay current with emerging legislation and guidance in the field and contribute to ensuring company-level awareness and compliance

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 biotechnology 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 13 Nov 2023, 6:57 AM