At a Glance
- Tasks: Lead global regulatory strategies for innovative medicines and vaccines.
- Company: Join GSK, a pioneering company dedicated to improving global health.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and excellence.
- Why this job: Make a real difference in patients' lives through impactful regulatory work.
- Qualifications: Bachelor's in Biological or Healthcare Science; experience in regulatory affairs preferred.
The predicted salary is between 80000 - 100000 € 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, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Associate Director Global Regulatory Strategy (GRS) will lead and execute regulatory strategies for global and regional assets, ensuring optimal labeling and approvals while 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 lifecycle.
- Foster strong matrix working relationships within GSK (to VP level) and facilitate dialogue across teams to optimize outcomes.
- Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes.
- 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.
- 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 Stevenage employer: WISE Campaign
At GSK, we are dedicated to fostering a dynamic and inclusive work environment that empowers our employees to thrive. As an Associate Director in Global Regulatory Strategy, you will be part of a team that is committed to innovation and excellence, with ample opportunities for professional growth and development. Our culture prioritises accountability and collaboration, ensuring that every team member contributes to our mission of improving global health while enjoying the benefits of a supportive workplace.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in Stevenage
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to regulatory affairs. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Showcase Your Expertise
When you get the chance to chat with potential employers, make sure to highlight your experience in drug development and regulatory affairs. We want to see you confidently discuss your past projects and how they align with GSK's mission to impact patient health.
✨Prepare for Interviews
Do your homework on GSK and their current projects. We recommend practising common interview questions and preparing examples of how you've tackled regulatory challenges in the past. This will show you're not just a fit for the role, but also passionate about their goals.
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take the initiative to engage with us directly.
We think you need these skills to ace Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in Stevenage
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 GSK's mission to impact patient health.
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 ability to communicate effectively.
Highlight Relevant Experience:Don’t forget to emphasise your experience in drug development and regulatory submissions. Mention specific projects or achievements that showcase your expertise in leading global and regional strategies.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way to ensure your application gets the attention it deserves and allows us to keep track of all candidates efficiently.
How to prepare for a job interview at WISE Campaign
✨Know Your Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in oncology. Understand the drug development process inside out, and be ready to discuss how your experience aligns with GSK's ambitious goals for patient health.
✨Showcase Your Collaboration Skills
GSK values strong teamwork, so be prepared to share examples of how you've successfully worked in cross-functional teams. Highlight any experiences where you’ve led discussions or facilitated dialogue across different departments to achieve project objectives.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving abilities in regulatory challenges. Think of specific instances where you had to derive creative solutions while balancing compliance and agency expectations, and be ready to explain your thought process.
✨Communicate Clearly and Confidently
Strong communication skills are key for this role. Practice articulating your thoughts clearly, especially when discussing complex regulatory strategies. Use concise language and impactful examples to demonstrate your expertise and make a lasting impression.
