At a Glance
- Tasks: Lead regulatory strategy for innovative medicines and vaccines, ensuring compliance and successful market entry.
- Company: GSK, a global biopharma company with a mission to impact 2.5 billion lives by 2030.
- Benefits: Hybrid working model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic environment with a focus on innovation and patient outcomes.
- Why this job: Join a team that combines science and technology to transform patient lives.
- Qualifications: Bachelor’s degree in life sciences and extensive regulatory experience required.
The predicted salary is between 99000 - 121000 £ per year.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing.
Position Summary
Ensure the development of appropriate regulatory life-cycle strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/Integrated Asset Plan (IAP) to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal GSK process/policy and with appropriate regulatory requirements.
Responsibilities
- Accountable to Global Regulatory Strategy Therapeutic Area Head for development of appropriate regulatory life-cycle management and expansion 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 and/or strategic activities for GSK’s Established Products (EP) portfolio.
- 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.
Basic Qualification
- Bachelor’s degree in a life science, pharmacy, medicine, or related discipline.
- Extensive experience of all phases of the drug development process in regulatory affairs.
- Proven experience of leading development, submission and approval activities.
- Extensive knowledge of clinical trial and licensing requirements in priority markets.
Preferred Qualification
- Advanced degree (MSc, PharmD, PhD) or equivalent professional qualification.
- Experience managing budgets, external vendor relationships and centre-of-excellence style teams.
- Proven success with inspection readiness and managing regulatory compliance programmes.
Location and Working Model
This role is based in the United Kingdom and operates in a hybrid working model. You will be expected to spend regular time on-site to lead the team and work with cross-functional colleagues.
How to apply
Please submit your CV and a short cover letter explaining why this role matters to you and how your skills will help us deliver patient-focused regulatory outcomes.
Skills
- Business Resilience
- Communication
- Digital Fluency
- Matrix Leadership
- Pharmaceutical Regulatory Compliance
- Policy Advocacy
- Regulatory Strategies
- Resource Management
- Stakeholder Management
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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