Regulatory Affairs Director (RAD)
Qualifications
- Advanced Degree in Life Science or related discipline.
- 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.
- Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development.
- Proven track record of regulatory drug development including product approval/launch.
- Experience in leading Major Health Authority interactions.
- Ability to think strategically and critically and evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business critical and high-profile development program.
Benefits
- Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.
- Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife.
- Vision Insurance: Synectics offers eligible employees vision insurance through VSP.
- 401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan.
Schedule
The schedule is not specified in the job posting.
Pay
The pay is not specified in the job posting.
Skills
The skills required are not explicitly stated in the job posting beyond the qualifications listed.
About the Role
Join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio!
Responsibilities
Provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead. Plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.