about 1 month ago
Director, Regulatory Affairs
Location: San Francisco, CA
Type: Permanent position
This is an exciting opportunity to work on this biotech's newly commercialized Oncology product among other biologic products in their expansive pipeline. This company is actively growing and hiring for 2 new Regulatory professionals to support the development and life-cycle management of the newly marketed Oncology product.
The Director, Regulatory Affairs will report directly to the VP, Regulatory Affairs. This professional will be responsible for leading the regulatory strategy of the in-licensed oncology product and also leading meeting preparation for all health authority interactions.
- Advise on regulatory strategy for development of drugs in the company's pipeline.
- Practice regulatory intelligence through the observation, collection and evaluation of regulatory information in order to create a strategy for timely drug development.
- Represents Regulatory Affairs at product development team meetings.
- Plans, writes and executes document packages for regulatory submissions to support regulatory applications including investigational and marketing applications (IND, CTA, Orphan Drug Application, NDA, NDS, MAA etc.)
- Reviews clinical study documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US and Ex-US country requirements for initiation of clinical sites and drug shipments.
- Responsible for preparing for meeintgs wuth health authorities
- 6-8 years of regulatory pharmaceutical experience
- BA/BS or advanced degree in life sciences
- Biologics/BLA experience required; biosimilars experience preferred
- Experience in Oncology drug development highly preferred.
I am a Regulatory Affairs market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Nikita Madan at 619-350-6341 or at email@example.com