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Director of Pediatric Drug Development
2 weeks ago
Senior Regulatory Affairs Director
Global Therapeutic Area Regulatory Liaisons is a core function within our organization, acting as a critical strategic partner across drug discovery, development and commercial teams. The successful candidate will develop regulatory strategic options and work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings.
Key Responsibilities:
- Accountable for oversight and leadership of the development and successful completion of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across the Virology, Oncology and Inflammation TAs.
- Makes significant contributions to the ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration across Global TA regulatory liaisons and cross-functional teams.
- Represents the company in negotiations with regulatory authorities as needed.
- Proactively identifies regulatory or pediatric-related risks/issues and ensures timely development of mitigation and/or contingency plans.
- Manages one or more direct reports.
Requirements:
MA/MS/MBA/PharmD/PhD with 12+ years' relevant experience. Extensive experience in Global Regulatory Affairs and developing global pediatric regulatory strategies. Experience working with one or more therapeutic areas and varying stages of drug development is strongly preferred.
About Us:
We are a healthcare company that creates life-changing scientific innovations. Our mission requires collaboration, determination and a relentless drive to make a difference. Every member of our team plays a critical role in the discovery and development of innovative therapies that improve lives and ensure access to these therapies across the globe.
Benefits:
Competitive compensation package. Opportunities for professional growth and development. Collaborative and dynamic work environment.
Equal Employment Opportunity:
It is the policy of our company to recruit, select and employ the most qualified persons available for positions throughout the company. We prohibit discrimination based on any protected characteristic or prohibited ground.
