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- Tasks: Lead regulatory strategies and ensure compliance for GSK's Established Products.
- Company: GSK is a global biopharma leader focused on vaccines, medicines, and innovation.
- Benefits: Enjoy an inclusive work environment with opportunities for growth and development.
- Why this job: Join a mission-driven team making a real impact in healthcare and science.
- Qualifications: Bachelor's degree and 5+ years in regulatory affairs; leadership experience required.
- Other info: Opportunity to work with global teams and influence drug development.
The predicted salary is between 72000 - 108000 £ per year.
Job Purpose
Ensure the development of appropriate regional regulatory strategy(ies) and their execution for assigned asset(s) consistent with the strategic activities for GSK's Established Products (EP) portfolio. Maintain/ensure compliance with internal GSK processes/policies and regional regulatory requirements.
Key Responsibilities
- Accountable to the Senior/Executive Director for developing and delivering regional and/or global regulatory strategies.
- Lead interactions with local/regional regulatory authorities.
- Implement regional strategies, lead regulatory interactions, ensure compliance, advocate persuasively to senior leaders and authorities, and assess potential in license molecules.
Why you?
Basic Qualifications:
- Bachelor's degree
- 5+ years industry regulatory affairs experience
- 5+ years leading matrixed teams across global regions
Preferred Qualifications:
- PhD or Master's in life sciences or pharmacy
- Strong technical knowledge of regulatory compliance
- Experience with regulatory officials and advocacy
- Extensive drug development regulatory experience
- Proven leadership in regional development, submission, and approval activities
- Knowledge of clinical trial and licensing requirements globally
Why GSK?
GSK is a global biopharma company committed to uniting science, technology, and talent to combat disease, focusing on vaccines, medicines, and the immune system. We value our people and aim to create an inclusive environment where everyone can thrive. Join us in our journey to get Ahead Together.
Regulatory Affairs Director - Established Products employer: ENGINEERINGUK
Contact Detail:
ENGINEERINGUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Director - Established Products
✨Tip Number 1
Familiarise yourself with GSK's Established Products portfolio and their recent regulatory strategies. Understanding their current projects and challenges will help you tailor your discussions during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with GSK or similar companies. Attend industry conferences or webinars to make connections that could provide insights or referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led regulatory strategies in the past. Highlight your experience with compliance and advocacy, as these are crucial for the role.
✨Tip Number 4
Stay updated on global regulatory trends and changes, particularly those affecting established products. This knowledge will demonstrate your commitment to the field and your ability to adapt to evolving regulations.
We think you need these skills to ace Regulatory Affairs Director - Established Products
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Director position. Tailor your application to highlight your relevant experience in regulatory strategy and compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 5+ years of industry regulatory affairs experience and any leadership roles you've held. Provide specific examples of how you've led teams and interacted with regulatory authorities.
Craft a Compelling Cover Letter: Your cover letter should not only express your interest in the role but also demonstrate your understanding of GSK's mission and values. Discuss how your background aligns with their focus on vaccines and medicines.
Proofread Your Application: Before submitting, carefully proofread your application materials for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at ENGINEERINGUK
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulatory frameworks relevant to GSK's Established Products. Familiarise yourself with both local and global regulations, as well as any recent changes that may impact the industry.
✨Showcase Leadership Experience
Prepare to discuss your experience in leading matrixed teams. Highlight specific examples where you successfully navigated complex regulatory challenges and how you advocated for your team’s strategies to senior leaders.
✨Demonstrate Technical Knowledge
Be ready to dive deep into your technical knowledge of regulatory compliance. Discuss your understanding of clinical trial requirements and drug development processes, as this will be crucial in showcasing your expertise.
✨Engage with Real-World Scenarios
Think of real-world scenarios where you had to interact with regulatory authorities. Prepare to share these experiences, focusing on how you built relationships and effectively communicated to advocate for your projects.
