Regulatory Affairs Vice President
1 month ago
Seeking a highly experienced Regulatory Affairs professional to lead the NDA process through launch and provide regulatory leadership through the regulatory strategy of product development and approval.
Responsibilities:
- Provide knowledge of global quality/regulatory guidelines and ensure requirements are met across programs
- Partner with internal senior leadership to collaborate on cross-functional projects and provide global regulatory plans to align with company objectives
- Have ownership of relevant regulatory submission deliverables
- Provide leadership and oversight of all critical global regulatory submissions (pre-IND through post-marketing) to FDA and RoW notified bodies
- Represent the Regulatory department in senior management discussions and present strategies, risk assessments, and recommendations
- Provide hands on leadership for the Regulatory department
Qualifications:
- 15+ years of experience in Regulatory Affairs in biopharma/biotech/pharma
- Advanced degree preferred (MD, PhD, PharmD, MS)
- Previous NDA and small molecule experience is desired
- Has experience managing multiple assets in a product pipeline
- Previous managerial experience is preferred
- Well versed in drug development process and regulatory requirements, as well as a good understanding of the underlying science
- Excellent project management skills, with ability to manage multiple projects and prioritize appropriately
- Ability to rapidly understand & analyze complex problems/situations
- Ability to lead teams under tight timelines and be willing to contribute significantly to day-to-day operations as needed
Company Description:
A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign.
Job Responsibilities:
- Conducting Post Market Activities and Post Market Surveillance
- Managing Customer and Product Complaint Investigation programs
Education and Experience:
- 1 YR. of experience in a technical role in the medical device/pharma/biotech industry
- Bachelor's degree
- Computer proficiency
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