At a Glance
- Tasks: Lead global regulatory strategies and ensure compliance for innovative healthcare products.
- Company: Join GSK, a leading global healthcare company committed to improving lives.
- Benefits: Competitive salary, diverse work environment, and opportunities for professional growth.
- Other info: Collaborative culture with strong focus on innovation and process improvement.
- Why this job: Make a real impact in drug development and regulatory affairs in a dynamic team.
- Qualifications: Bachelor’s degree in Biological or Healthcare Science; experience in regulatory affairs preferred.
The predicted salary is between 60000 - 80000 € per year.
Site Name: Baar Onyx, GSK HQ, Stevenage
Posted Date: May
Lead and execute regulatory strategies for global and regional assets, ensuring optimal labeling and approvals and maintaining compliance with internal and external requirements. Work in cross‑functional and matrix environments to deliver project objectives across multiple regions.
Responsibilities
- Develop and implement global/regional regulatory strategy for assigned assets in alignment with Medicines Development Strategy and Integrated Asset Plan.
- Work closely with Early/Medicine Development Teams (EDT/MDT) or Global Regulatory Lead (GRL) to ensure robust regulatory strategies that meet key market requirements.
- Manage interactions, reviews and submissions with regional/local regulatory authorities for product development and approval.
- Collaborate with commercial teams in the local region to secure the best possible labeling based on available data.
- Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision‑making.
- Ensure compliance with global, regional and local regulatory requirements throughout the product life cycle.
- Foster strong matrix working relationships within GSK up to VP level and facilitate dialogue across teams to optimize outcomes.
- Drive process improvement, innovation and performance excellence through development and implementation of strategic changes.
Qualifications & Skills
- Minimum: Bachelor’s degree in Biological or Healthcare Science.
- Experience in all phases of drug development process, preferably in regulatory affairs.
- Experience in Oncology Global Regulatory Affairs.
- Proven expertise in leading global and regional development, submission and approval activities.
- Comprehensive knowledge of clinical trial and licensing requirements across major regional/global markets.
- Ability to derive creative and compliant solutions to regulatory challenges while balancing agency expectations.
- Strong communication skills, particularly in writing, with clarity and impact.
Preferred Qualifications & Skills
- PhD in Biological or Healthcare Science.
- Demonstrated knowledge of oncology therapy areas and ability to develop specialist knowledge of assigned assets.
- Proficiency in digital fluency tools to enhance project delivery, efficiency and innovation.
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 (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in London employer: Gsk
GSK is an exceptional employer, offering a dynamic work environment at our Baar Onyx headquarters in Stevenage, where innovation and collaboration thrive. We prioritise employee growth through comprehensive training and development opportunities, fostering a culture of inclusivity and excellence. Join us to make a meaningful impact in global healthcare while enjoying the benefits of a supportive team and a commitment to work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups. The more you engage with others, the better your chances of hearing about job openings before they even hit the market.
✨Ace the Informational Interview
Don’t be shy to reach out for informational interviews. It’s a great way to learn about the company culture and the role while making a lasting impression. Plus, it shows your genuine interest in the position!
✨Showcase Your Expertise
When you get the chance to chat with potential employers, make sure to highlight your experience in regulatory affairs and drug development. Share specific examples of how you've tackled challenges in the past – it’ll set you apart from the crowd!
✨Apply Through Our Website
Remember, applying through our website gives you a direct line to us! It’s the best way to ensure your application gets seen by the right people. So, don’t hesitate – hit that apply button and let’s get the conversation started!
We think you need these skills to ace Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Director role. Highlight your experience in regulatory affairs and oncology, and show how your skills align with our needs at StudySmarter.
Showcase Your Communication Skills:Since strong writing is key for this position, ensure your application is clear and impactful. Use concise language and structure your thoughts logically to demonstrate your communication prowess.
Highlight Cross-Functional Experience:We love seeing candidates who can work well in matrix environments. Share examples of how you've collaborated with different teams to achieve project objectives, especially in regulatory strategy.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Gsk
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of global and regional regulatory strategies, especially in oncology. Familiarise yourself with the latest trends and requirements in drug development to show that you're not just a candidate, but a knowledgeable partner.
✨Showcase Your Collaboration Skills
Since this role involves working in cross-functional teams, be ready to share examples of how you've successfully collaborated with different departments. Highlight any experiences where you’ve led discussions or facilitated dialogue to achieve project objectives.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in regulatory challenges. Think of specific situations where you had to derive creative solutions while balancing compliance and agency expectations. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Communicate Clearly and Confidently
Strong communication is key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory concepts. Consider doing mock interviews with a friend to refine your delivery and ensure your points come across with impact.
