Director Legal, Manufacturing Division
Core
Provide legal support and counseling to business clients on manufacturing compliance issues, including cGMP, globally.
Role type
Director, Legal (Manufacturing Regulatory)
Builds
Compliant manufacturing operations and regulatory submissions
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
US law school graduate, Bar admission, 5+ years regulatory experience, cGMP knowledge, FDA/EMA interaction experience
Preferred skills
Pharmaceutical industry experience, regulatory authority negotiation
Technologies
None
Responsibilities
Provide day-to-day legal advice to quality and supply chain organizations; Review regulatory submissions and provide strategic advice on interactions with regulators; Provide legal support for regulatory inspections; Maintain understanding of current Good Manufacturing Practices (cGMP); Provide advice on manufacturing-related agreements.
Seniority
Director, strategic & operational leadership