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- Tasks: Lead regional regulatory strategy and ensure compliance for innovative medicines.
- Company: Join GSK, a global biopharma company with a mission to impact 2.5 billion lives.
- Benefits: Competitive salary, hybrid work, private healthcare, and generous parental leave.
- Other info: Collaborative culture focused on accountability and making a real difference.
- Why this job: Shape regulatory strategies that improve patient access and drive innovation.
- Qualifications: Bachelor's in life sciences; experience in regulatory affairs preferred.
The predicted salary is between 86000 - 143750 £ 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
Lead the development of appropriate business-focused, high-quality, timely regional regulatory strategy and its execution for assigned asset(s), consistent with relevant enterprise goals and respective product profile. This goal has to be achieved as a component of an overall global regulatory approach while ensuring compliance with both internal GSK process/policy and with regional regulatory requirements.
Key Responsibilities
- Responsible for the development of optimal regional regulatory strategy and for its delivery according to plan.
- Provide deep regulatory knowledge and international markets expertise, as well as knowledge of the therapeutic area, to anticipate opportunities and risks.
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective.
- Proactively develop and implement regional regulatory strategy aligned with enterprise goals and local opportunities.
- Represent Regulatory function in collaboration with regional stakeholders.
- Contribute to the development of Global Regulatory Strategy (GRS) ensuring alignment with core product labeling and regional regulatory requirements.
- Collaborate with GRL and LOC RA at early stages of development.
- Lead the Regional Strategy in interactions between GRL and LOC RA.
- Seek processes optimization opportunities, sharing learnings and best practices across the teams.
- Accountable for complete, accurate, and timely communication on the relevant assets’ key milestones.
- Anticipate and escalate risks and issues related to regulatory strategy and supply disruption in region.
- Lead and implement regional innovation initiatives, aligned to GRA objectives.
Basic Qualification
- Bachelor Degree in a scientific discipline such as life sciences, pharmacy, medicine, or equivalent.
- Proven experience of leading regional development, submission and approval activities.
- Extensive experience of all phases of the drug development process in regulatory affairs.
- Extensive knowledge of clinical trial and licensing requirements in all major countries in the region.
Preferred Qualification
- Advanced degree (Masters, PharmD, MD, or PhD) in a relevant scientific discipline.
- Direct experience in developmental regulatory strategy.
- Experience contributing to regulatory policy, advocacy, or interacting with regional health authorities.
- Experience coaching and developing multi-cultural teams.
Work arrangement
This role is based in London, Siena, Wavre (Belgium), or Poznan and is hybrid. Regular on-site collaboration is expected.
What we value in you
You are collaborative, curious, and accountable. You make clear recommendations and balance scientific, regulatory, and commercial considerations.
If this role matches your experience and ambitions, please submit your CV and a short cover letter describing how you would contribute to portfolio strategy and regulatory optimisation in this role.
Regional Regulatory Affairs Director (International) employer: Gsk
Contact Detail:
Gsk Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regional Regulatory Affairs Director (International)
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching GSK's values and recent projects. Show us that you’re not just interested in the role, but that you genuinely care about our mission to impact health positively. Tailor your responses to reflect how your experience aligns with our goals.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. We want to see you at your best, so don’t hesitate to rehearse those tricky questions.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind. Plus, it’s a great opportunity to reiterate your enthusiasm for the role and how you can contribute to GSK.
We think you need these skills to ace Regional Regulatory Affairs Director (International)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Regional Regulatory Affairs Director. Highlight your relevant experience in regulatory strategy and your understanding of the drug development process. We want to see how your background aligns with our ambitious goals!
Craft a Compelling Cover Letter: Your cover letter should not just repeat your CV but tell us why you're passionate about this role. Share specific examples of how you've contributed to regulatory optimisation in the past. This is your chance to show us your personality and enthusiasm!
Showcase Your Collaborative Spirit: Since this role involves extensive collaboration, make sure to highlight your teamwork skills. Share instances where you’ve successfully worked with cross-functional teams or navigated complex stakeholder environments. We value collaboration at StudySmarter!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Gsk
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regional regulatory requirements and the drug development process. GSK is looking for someone who can navigate complex regulations, so be prepared to discuss specific examples from your experience that demonstrate your expertise.
✨Showcase Your Collaborative Skills
This role involves working with various stakeholders, so highlight your experience in cross-functional collaboration. Be ready to share stories about how you've successfully liaised with different teams or health authorities to achieve regulatory goals.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think through potential risks and mitigation strategies related to regulatory submissions and approvals, and be ready to articulate your thought process clearly.
✨Align with GSK's Values
GSK values ambition for patients and accountability for impact. During your interview, express how your personal values align with theirs. Share examples of how you've made a positive impact in your previous roles, especially in relation to patient outcomes.