About this role
Role Overview
- Ensure the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP).
- Accountable to GRL (if not the GRL) and/or Global Regulatory TA Head for development of appropriate regulatory strategy(s) and for delivery according to plans.
- Works with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program.
- Provides direct line management responsibility for TG staff.
- Manage performance for direct reports (e.g. My Plan, Reward, Recognition, PIPs, etc.).
- Proactively develop a regulatory strategy focused on the key markets identified.
- Lead regulatory interactions and the regulatory review processes.
- Ensure compliance with regulatory requirements at all stages of product life.
Requirements
- Bachelor’s degree in life sciences, pharmacy, medicine or a related discipline.
- Extensive experience (7+ years) of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
- Extensive knowledge of relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area.
- Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority.
- Extensive knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally.
- Ideally, proven experience of leading regulatory activities outside local region.
- Advanced degree (Master’s, PharmD, MD or PhD) in a life science or related field is preferred.
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave