Job Details
We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE).
As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND and IND submissions). Experience with BLA submissions is a plus. This role offers a flexible and diverse work environment and an excellent benefit package.
Key Responsibilities:
- Develop and implement regulatory strategies to support the early development of cell therapy products
- Lead interactions with regulatory agencies to ensure compliance with all relevant regulations and guidelines for pre-IND and IND submissions
- Provide guidance and support to cross-functional teams on regulatory requirements throughout the early development process
- Oversee the preparation and submission of regulatory documents, including INDs and other regulatory filings
- Stay current on regulatory trends and developments in early development of cell therapy products to ensure compliance and strategic advantage
Qualifications:
- Bachelor's degree in a scientific or related field required; advanced degree preferred
- Minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry with at least 5 years in cell therapy
-3 years of previous leadership experience preferred
- Demonstrated experience in early development regulatory affairs, with specific experience in pre-IND and IND submissions
- Experience with BLA submissions is a plus
- Strong understanding of FDA and international regulatory requirements for early development of cell therapy products
- Excellent communication and leadership skills
- Ability to work effectively in a fast-paced, dynamic environment
This is an exciting opportunity to join a growing company at the forefront of cell therapy development. If you have the experience and qualifications required for this role, we encourage you to apply today.