Regulatory Affairs Director
13 hours ago
The Director of Regulatory Affairs will provide strategic leadership on global regulatory activities for assigned products. Key responsibilities include providing regulatory expertise, developing strategic plans, and ensuring compliance with regulations and project timelines.
Key Responsibilities:
- Provide interpretation of regulatory authorities' feedback, policies, and guidelines.
- Lead the development of regulatory strategic plans and own the preparation of major clinical submissions.
- Work with project teams to resolve complex project issues and ensure compliance with regulations.
- Utilize regulatory expertise to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
- Provide interpersonal support and lead personnel.
Requirements:
- Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- Minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
- Excellent written and verbal communication skills, along with a MD, Ph.D., or Pharm D. degree.
What We Offer:
- Comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.
- Inclusive and diverse culture that provides opportunities for growth and development.
Regeneron Pharmaceuticals is an Equal Opportunity Employer.
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