over 1 year ago
VP, Global 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 VP, Global Regulatory Affairs will act as a regulatory lead, in partnership with the EVP, and will be reponsible for the regulatory strategy and content of all regulatory submissions for the oncology franchise. The VP, Global Regulatory Affairs will also interface directly with global regulatory bodies.
- Develop global regulatory strategies in order to acheive regulatory approval in US, EU, Japan and ROW as soon as possible.
- Establish relationships with Regulatory Agencies and participate in negotiations.
- Act as Global Regulatory Affairs representative at project team meetings and coordinate workflow between departments as well as CROs.
- 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.
- BA/BS in Life Sciences field required, Ph.D highly preferred
- 10-12 years of Regulatory Affairs experience in pharmaceutical industry
- Experience working on development, approval and evaluation of Oncology programs required
- Expert knowledge of US and international laws and regulations pertaining to drug development required.
- Experience in Regulatory and drug development with late stage development/marketed products required
- BLA/Biologics experience required
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