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Vice President Regulatory Affairs
2 weeks ago
My client is a Top 10 Pharma looking for a new VP Regulatory affairs. They have been a secure fortune 500 company for many years and are expanding their team across the US and globally. With over 2000 employees they have a track record of leading the industry and expanding their clinical settings.
As the Vice President of Regulatory Affairs, you will play a pivotal role in our organisation by effectively managing regulatory strategies and compliance efforts. Your responsibilities include liaising with regulatory agencies, leading submissions, and ensuring timely approvals. You'll collaborate with cross-functional teams to achieve regulatory milestones and maintain compliance with global regulations.
Regulatory Strategy and Leadership:
- Develop and execute regulatory strategies aligned with organisational goals.
- Serve as a key contact for regulatory agencies and coordinate meetings.
- Lead the preparation of regulatory submissions.
Global Project Support:
- Participate in project team meetings and provide regulatory guidance.
- Collaborate with various disciplines to gather information for filings.
Continuing Education:
- Stay current with regulations and attend relevant conferences.
- Research answers to regulatory affairs questions.
Education:
- Bachelor's degree required.
- Advanced degree (e.g., Masters, PharmD, Ph.D., MD) preferred
Experience:
- Minimum 10 years in the pharmaceutical industry.
- At least 7 years in regulatory affairs.
- Familiarity with IND and NDA/BLA processes.
Competencies:
- Strong communication skills (oral and written).
- Ability to work in a team environment.
- Detail-oriented and proactive.
- Occasional travel up to 30% (global).
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