Senior Director, GRS Oncology, Global Regulatory Affairs
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Upper Providence • Maryland • Massachusetts • United States
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Salary
💰 $222,000 - $370,000 per year
Job Level
About the role
- Ensure the development of appropriate regulatory strategies and execution for assigned asset(s) consistent with Medicines Development Strategies/ Integrated Evidence Strategies.
- Work with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place.
- Proactively develop regulatory strategies and promote innovative regulatory approaches.
- Ensure implementation of the regulatory strategies in support of the project priorities.
- Lead regulatory interactions and the regulatory review processes.
- Advocate persuasively to senior leaders in GSK and in Health Authorities.
Requirements
- Bachelor’s degree in a biological, life science, or healthcare field.
- Significant experience in regulatory affairs (10+ years)
- 5 + years experience across all phases of drug development and regulatory submissions.
- Track record leading global or regional regulatory strategy and interactions with health authorities.
- Experience working in complex matrix teams with clinical, CMC, commercial, and safety functions.
- Strong written and verbal communication skills with ability to present clearly to senior leaders and regulators.
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsregulatory strategydrug developmentregulatory submissionsregulatory interactionsregulatory review processes
Soft Skills
communication skillspresentation skillsleadershipadvocacy
Certifications
Bachelor’s degree