Director, Global Regulatory Lead (Strategy)
As one of the fastest and largest growing pharmaceutical companies in the Boston Area, I am working with my client on a Director, Global Regulatory Strategy Lead position. The company is looking for a highly motivated, Director level individual who wants to join a dynamic and fast-paced organization, by helping to empower and lead the Global Regulatory Affairs Team. If you are looking for a new opportunity that will give you an amazing chance to start with a growing company that loves to promote from within, now is your chance!
In this role you will be responsible for:
- Define, develop, and lead all global Regulatory strategies
- Lead the Regulatory department, while working cross-functionally amongst all other teams regional counterparts
- Act as the direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports of junior staff as needed.
- Provide leadership and development for direct reports and for those that serve as global regulatory leads responsible for the design and execution of GRA strategies
- Overseeing vendor responsibility for regulatory activities and submissions related to projects within scope.
In this role you will be required to have:
- 10+ years of pharmaceutical industry experience
- At least 8 years of Regulatory experience or 6+ years Regulatory and/or related experience
- Solid working knowledge of drug development process and regulatory requirements (i.e understanding of broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
- Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.