Senior Director / VP Regulatory Affairs


Job ID 19-00059

Industry Pharma

Job Type Permanent

Location East Windsor, NJ

Description

Responsibilities
- Keep abreast of current regulatory requirements and provide regulatory advice
- Work on INDs, NDAs, CTAs, BLAs and MAAs in different regions around the world, including nonclinical, and clinical activities
- Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
- Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams
- Lead interactions with regulatory agencies for projects and products including liaising and negotiating with FDA, EMA and other HAs interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor
- Independently lead the preparation and timely submission of regulatory filings, maintain existing products upto regulatory standards and plan for life cycle management
- Provide regulatory affairs representation on project teams; lead regulatory sub-teams. Act as single point of RA contact on cross-functional teams; foster a global view as a member of the development team.
- Mentor and provide guidance to junior RA representatives and build a robust infrastructure to support the growing needs of the business.



Qualifications

Education and Experience
- Advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.)
- Experience in the pharmaceutical industry (8-10 years), including direct oncology regulatory affairs with the FDA preferred
- Deep and broad knowledge of regulatory affairs strategy ; direct experience with pharmaceutical regulatory submissions and product approvals in the US. EU and global experience preferred.
- A proven track record of effective collaboration with regulatory agencies, including the FDA
- Experience with and line extensions strategy for marketed products preferred
- Excellent verbal and written communication skills
- Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets
- Creative problem solving and strategizing abilities
- 30% Travel required