At a Glance
- Tasks: Lead global regulatory strategies for innovative healthcare products and ensure compliance.
- Company: Join GSK, a leading global healthcare company committed to innovation.
- Benefits: Competitive salary, diverse work environment, and opportunities for professional growth.
- Other info: Collaborative culture with strong focus on process improvement and innovation.
- Why this job: Make a real impact in the healthcare sector while working with cutting-edge therapies.
- Qualifications: Bachelor’s degree in Biological or Healthcare Science; experience in regulatory affairs preferred.
The predicted salary is between 80000 - 100000 € per year.
Associate Director Global Regulatory Strategy (GRS) (m/f/d) 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.
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.
Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in London employer: GlaxoSmithKline
GSK is an exceptional employer that fosters a collaborative and innovative work culture, particularly for the Associate Director, Global Regulatory Strategy role. With a strong emphasis on employee growth and development, GSK offers opportunities to lead impactful regulatory strategies in a dynamic environment, ensuring compliance while driving process improvements. Located in a vibrant area, employees benefit from a supportive network and access to cutting-edge resources, making it an ideal place for those seeking meaningful and rewarding careers in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working at GSK. A friendly chat can open doors and give you insider info on what they're really looking for.
✨Tip Number 2
Prepare for interviews by diving deep into GSK's recent projects and regulatory strategies. Show us you know your stuff and can contribute to their goals right from the get-go!
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Associate Director in Global Regulatory Strategy. We want to hear how you can tackle challenges and drive innovation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're serious about joining the team.
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, especially in oncology, and how it aligns with our needs at StudySmarter.
Showcase Your Communication Skills:Since strong writing skills are 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 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, as this will resonate with our collaborative culture.
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 GlaxoSmithKline
✨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 clinical trial requirements and licensing regulations across major markets. This will show that you're not just a candidate, but someone who understands the landscape.
✨Showcase Your Cross-Functional Skills
Since the role involves working in cross-functional teams, be ready to discuss your experience collaborating with different departments. Prepare examples of how you've successfully navigated matrix environments and driven projects forward by fostering strong relationships.
✨Communicate Clearly and Confidently
Strong communication skills are key for this position. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory concepts. Use specific examples from your past experiences to demonstrate your ability to convey information effectively.
✨Be Ready to Innovate
The job requires driving process improvement and innovation. Think about times when you've implemented strategic changes or found creative solutions to regulatory challenges. Be prepared to share these stories, as they will highlight your proactive approach and problem-solving skills.
