Director of Regulatory Affairs
Join a global, diversified pharmaceutical company committed to enriching lives through innovative healthcare solutions. We are seeking a Director of Regulatory Affairs to lead regulatory strategy and execution for our prescription pharmaceutical portfolio. This is an exciting opportunity to be part of a collaborative, forward-thinking team that actively shapes the future of healthcare.
The Director will be responsible for...
- Develop and lead regulatory strategies for PRESCRIPTION/BRANDED pharmaceutical products across their life-cycle, from development through post-approval.
- Serve as a core member of cross-functional product development teams, providing regulatory guidance and ensuring alignment with global requirements.
- Oversee the preparation and submission of regulatory filings, ensuring timely, high-quality documentation that meets all agency expectations.
- Coordinate with global regulatory counterparts to ensure regional compliance and integration into overall product strategy.
- Monitor and interpret evolving regulatory policies and guidance to assess impact on current and future products.
- Collaborate with internal stakeholders (e.g., Quality, Compliance) during regulatory inspections and audits.
- Provide strategic input to internal review boards and senior leadership on regulatory matters.
- May lead or mentor regulatory staff and contribute to due diligence for new product opportunities.
The Director will have the following qualifications…
- Bachelor's degree in a science or health-related field required; advanced degree (MS, PharmD, PhD, MD) preferred.
- Minimum of 10 years of regulatory affairs experience in the pharmaceutical industry.
- Proven expertise in regulatory strategy, submissions, and life-cycle management for prescription products.
- Strong knowledge of domestic and international regulatory requirements and guidance.
- Excellent communication, leadership, and cross-functional collaboration skills.
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