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 strong career advancement potential.
- 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.
The 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.
Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in Stevenage employer: Job Search Place Limited
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 collaboration and accountability, ensuring that every team member contributes to our mission of improving global health while enjoying a supportive workplace in a vibrant location.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in Stevenage
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at GSK. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Research GSK’s recent projects and their impact on patients. This shows you're genuinely interested and ready to contribute to their ambitious goals.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Associate Director in Global Regulatory Strategy. Keep it concise but impactful—show them why you're the perfect fit!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the GSK team and making a difference.
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 Job Search Place Limited
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of global and regional regulatory strategies, especially in the oncology space. Familiarise yourself with the latest trends and requirements in drug development to show that you're not just a candidate, but a knowledgeable partner who can contribute to GSK's ambitious goals.
✨Showcase Your Communication Skills
Since strong communication is key for this role, prepare to demonstrate your ability to convey complex regulatory information clearly and effectively. Think about examples from your past experiences where you successfully communicated with cross-functional teams or regulatory authorities.
✨Prepare for Scenario Questions
Expect questions that assess how you would handle specific regulatory challenges. Prepare by thinking through potential scenarios you might face in the role and how you would approach them. This will help you showcase your problem-solving skills and strategic thinking.
✨Highlight Your Collaborative Spirit
GSK values collaboration across teams, so be ready to discuss how you've worked in matrix environments before. Share examples of how you’ve built relationships and facilitated dialogue to achieve project objectives, as this will resonate well with their culture.
