VP Clinical & Regulatory Affairs
- Doctorate Level
- 15 years of experience in Clinical and Regulatory affairs
- Experience in all aspects of regulatory submissions and approvals
- Ability to thrive in dynamic early stage business environment
- Development of strategic and tactical plans to obtain US Regulatory approval for new products
- Design clinical studies that comply with regulatory guidelines and secure the greatest probability of approval
- Collaborate with the senior management team to define the product development portfolio and business strategy
VP Pharmaceutical Development Job Description
The Vice President is responsible for:
1) directing the formulation development, analytical method development, and process development activities for thin film products containing small molecules
2) production and quality control testing of clinical supplies.
3) ensuring compliance with requirements for CMC regulatory submissions.
4) reviewing study reports, manufacturing process documentation, investigator brochures, clinical study protocols, and clinical trial documentation for compliance with cGMPs, cGLPs and other appropriate regulations and guidelines for CMC related issues.
5) acting as liaison (with regulatory and quality personnel) with FDA, and other regulatory agencies for CMC issues.
6) reviewing proposed changes to regulated processes and /or products to identify regulatory implications.
7) working closely with quality systems organizations to identify and resolve CMC issues.
8) interacting with key scientific, clinical research, marketing and commercial personnel within and outside the Company to ensure timely and accurate regulatory compliance on CMC matters.
The ideal candidate will have:
1) 15+ years experience in industry as a CMC professional with successful NDA submissions and commercial product production.
2) experience in all phases of regulatory submissions and interactions regarding CMC issues, ideally including post-approval
experience with regulatory authorities on CMC issues.
3) senior management leadership experience for the CMC function in a pharmaceutical company,
4) excellent analytical, communication, presentation, and writing skills.
5) proven ability to work as a team member collaboratively with colleagues across all functions.
6) advanced degree in pharmaceutical sciences or chemistry
Submitting Resumes by Mail:
BioDelivery Sciences International
Attn: Office Manager
801 Corporate Center Drive, Suite 210
Raleigh, NC 27607
Submitting Resumes Online: