Vice President Regulatory Affairs
My client is a unique pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. With solid pharmaceutical partnerships in place, they plan on filing their second program to the FDA in 2017 and are looking for a Vice President of Regulatory Affairs to be the face and voice; leading of all regulatory developments. In this role, you will have a seat at the table when it comes to not only core team decision making, but also the governance of how this company evolves going forward. This opportunity will put you in the position for enormous growth potential to build your career in a collaborative, open minded setting where the sky is the limit!
Responsibilities:
- Develop robust regulatory strategies and policies
- Lead global regulatory intelligence initiatives
- Ensure effective planning, preparation and submission of IND’s, IMPD, NOC, and marketing license applications in the U.S. and globally
- Liaise closely with the CMC, clinical and project teams and partner with project team leaders to ensure all regulatory requirements are met, and all information needed for registration and ongoing product availability is produced
- Build, manage and effectively lead a team of regulatory global professionals and consultants
- Provide feedback, coaching and professional development opportunities for direct reports
- Establish project related goals and monitors timelines
Knowledge and Skills:
- Minimum of a BS in a scientific discipline. MS, PhD degree preferred but not required
- 15 years’ regulatory affairs experience in a pharmaceutical or biotech company, including senior management experience
- Proven ability to develop robust regulatory/clinical and CMC strategies
- Experience in negotiating with the FDA and other worldwide health agencies: anticipating concerns, proactively addressing issues and challenges, and effectively finding solutions
- In depth experience with the U.S. and European regulatory requirements, demonstrated by submission and approval of multiple successful NDA/MAA’s
- Experience and understanding of the major Asia Pacific and Latin America regulatory requirements, a plus
- Excellent leadership skills in managing and motivating a team of regulatory professionals