Job DescriptionOur 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 risks2) Manage activities with emphasis on regulatory strategy preparation, review and submission of documents for FDA and other regulatory authorities3) Review and provide input on all regulatory filing documents4) Lead and facilitate activities, including team preparation, for meetings with FDA and other regulatory authorities for development activities5) Be responsible for communicating with FDA and other regulatory authorities6) Identify issues and develop appropriate regulatory strategies to mitigate risks to filings7) Ensure stakeholders are informed of developments that may affect regulatory success8) Perform compliance functions within the company9) Coordinate and manage regulatory inspections, as needed10) Stay current with emerging legislation and guidance in the field and contribute to ensuring company-level awareness and complianceCritical Requirements1) 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 field2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)3) Recent experience in the biotechnology industry is strongly preferred4) Preference will be given to candidates with recent experience in regulatory affairs managementFor 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 DetailsBase Salary: Highly competitive package, commensurate with experience
- Published on 13 Nov 2023, 6:57 AM