Associate Director - Toxins

Proclinical is working with a leading dermatology company present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products, located in Bridgewater, NJ. Currently, we are searching for an Associate Director to drive global toxins strategies, ensure accuracy of regulatory submissions, and be an effective cross-departmental expert for communicating regulatory needs and guidelines.

Job Responsibilities:

• Responsible for parts of the global regulatory strategy within their toxins group as it relates to various regulatory submissions (i.e. IND, BLA, NDA, CTA, MAA)
• Accountable for the US regulatory strategy
• Coordinate elements of regulatory CMC with the Regulatory CMC group
• Be the FDA contact person for the client's toxins registration globally

Skills and Requirements:

• MS, PhD, or Pharmacist
• 5+ years experience in pharma/biotech regulatory environment
• Relevant experience contributing to BLAs, INDs, MAAs, CTAs, or NDAs

If you are having difficulty in applying or if you have any questions, please contact Eric Simpson at (+1) 617-401-2427 or e.simpson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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