Hamlyn Williams is partnered with a Global Commercial stage Biotech company that is expanding, and looking to add a Director, Regulatory Affairs Lead to the team.
As a Director, Regulatory Affairs you will lead in preparation of filing for IND, CTA and NDA submissions to FDA. Provide regulatory support and guidance for cross functional teams and ensure global regulatory requirements are considered and incorporated into clinical and commercial products.
Responsibilities:
Work cross functionally with QA, CMC, Clinical Development, Clinical Operations, Project Management, etc
Establish and implement global regulatory strategy and plan
Ensure all internal and external deliverables are met on time
Lead meetings as needed
Qualifications:
Bachelor's degree in Life Sciences or Chemistry; an advanced degree is preferred
Over 7 years of experience in the pharmaceutical or biotechnology industry
Minimum of 5 years of direct experience as a regulatory affairs lead
Proven experience in filing Investigational New Drug (IND) and New Drug Application (NDA) for small molecules
Demonstrated ability to develop global regulatory strategy plans for both early-stage and late-stage development projects
Proficient in interacting with the FDA
Strongly prefer candidates with experience in oncology drug development
Seniority level
Director
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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