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 drug development and improve patient outcomes worldwide.
- Qualifications: Bachelor’s degree in Biological or Healthcare Science; experience in regulatory affairs preferred.
The predicted salary is between 80000 - 100000 € per year.
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.
Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in Stevenage employer: Gsk
GSK is an exceptional employer, offering a dynamic work environment at our Baar Onyx headquarters in Stevenage, where innovation and collaboration thrive. Employees benefit from comprehensive professional development opportunities, a strong commitment to diversity and inclusion, and the chance to make a meaningful impact in global healthcare through cutting-edge regulatory strategies. Join us to be part of a forward-thinking team that values your expertise and fosters growth in the ever-evolving field of oncology.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Global Regulatory Strategy (GRS) (m/f/d) in Stevenage
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✨Ace the Interview
Prepare for your interviews by researching the company and the role inside out. We recommend practising common interview questions and having a few of your own ready to show your interest. Remember, confidence is key, so believe in yourself!
✨Follow Up
After an interview, don’t forget to send a thank-you email! It shows your appreciation and keeps you fresh in their minds. We suggest mentioning something specific from the conversation to make it personal.
✨Apply Through Our Website
When you find a role that excites you, apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always looking for passionate individuals to join our team!
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 the job description. We want to see how you can bring value to our team!
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. Remember, we’re looking for clarity in communication, so let your writing shine!
Highlight Your Collaborative Experience:This role involves working in cross-functional teams, so share examples of how you've successfully collaborated with others. Whether it’s with regulatory authorities or commercial teams, we want to see your teamwork in action!
Apply Through Our Website:We encourage you 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. Plus, it’s super easy to do!
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 asset.
✨Showcase Your Cross-Functional Skills
Since this role involves working in matrix environments, be ready to discuss your experience collaborating with different teams. Prepare examples of how you've successfully navigated cross-functional projects and built strong relationships to achieve common goals.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities in regulatory challenges. Think of specific situations where you had to balance compliance with agency expectations and prepare to share how you approached those challenges creatively.
✨Communicate Clearly and Confidently
Strong communication skills are key for this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory concepts. This will help you make a lasting impression during the interview.
