Director, Regulatory Affairs - Oncology
Director, Regulatory Affairs - Oncology
Hamlyn Williams
United States
See who Hamlyn Williams has hired for this role
Hamlyn Williams provided pay range
This range is provided by Hamlyn Williams. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
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
Referrals increase your chances of interviewing at Hamlyn Williams by 2x
See who you knowGet notified about new Director of Regulatory Affairs jobs in United States.
Sign in to create job alertSimilar jobs
People also viewed
-
Senior Director Regulatory Affairs
Senior Director Regulatory Affairs
-
Director of Regulatory Affairs
Director of Regulatory Affairs
-
VP & General Counsel
VP & General Counsel
-
Executive Director of Regulatory Affairs
Executive Director of Regulatory Affairs
-
Director/Senior Director, EU Regulatory Strategy
Director/Senior Director, EU Regulatory Strategy
-
Director / Sr. Director, Regulatory Affairs
Director / Sr. Director, Regulatory Affairs
-
Senior Director, Legal and Compliance (Attorney)
Senior Director, Legal and Compliance (Attorney)
-
Senior Director Regulatory Affairs
Senior Director Regulatory Affairs
-
Director, Regulatory CMC
Director, Regulatory CMC
-
Director of Legal Education - New York West
Director of Legal Education - New York West
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More