Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead the development and execution of regional regulatory strategies for pharmaceutical products.
- Company: GSK is a global biopharma company focused on advancing health through science and technology.
- Benefits: Enjoy a thriving workplace culture with opportunities for growth and well-being support.
- Why this job: Join a mission-driven team making a real impact on global health and patient outcomes.
- Qualifications: Bachelor's degree in a relevant field; experience in Regulatory Affairs is essential.
- Other info: Ideal candidates may have advanced degrees and strong advocacy skills.
The predicted salary is between 72000 - 108000 £ per year.
You will need to login before you can apply for a job.
Director, Regulatory Affairs – Specialty
Site Name: UK – London – New Oxford Street, Stevenage, Wavre
Posted Date: Nov 22 2024
Job Purpose
Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
Key Responsibilities
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
- Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
- Implement the regional strategy(s) in support of the project globally
- Lead regulatory interactions and the review processes in local region
- Ensure appropriate interaction with regional commercial teams in local region
- Ensure compliance with regional requirements at all stages of product life from C2MD
- Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
- Capable of providing assessment of potential in license molecules
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree
- Experience in Regulatory Affairs within a pharmaceutical organization
- Experience working with Global Health Authorities and submissions for Pharmaceutical products
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- PhD or Masters’ degree in life sciences or pharmacy
- Strong technical knowledge required to be able to assess regulatory compliance of products
- Ability to interact with regulatory officials and support advocacy initiatives
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.#J-18808-Ljbffr
Director, Regulatory Affairs - Specialty employer: ENGINEERINGUK
Contact Detail:
ENGINEERINGUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Regulatory Affairs - Specialty
✨Tip Number 1
Familiarize yourself with GSK's global regulatory strategy and recent submissions. Understanding their approach will help you align your experience with their needs and demonstrate your capability to contribute effectively.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with GSK or similar organizations. This can provide you with insights into the company culture and expectations for the role.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in regulatory affairs, particularly those involving interactions with health authorities. Highlighting your advocacy skills and successful outcomes will be crucial.
✨Tip Number 4
Stay updated on current trends and changes in regulatory requirements within the pharmaceutical industry. Being knowledgeable about these topics will show your commitment to the field and readiness to tackle challenges.
We think you need these skills to ace Director, Regulatory Affairs - Specialty
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Director, Regulatory Affairs - Specialty position. Understand the key responsibilities and qualifications required, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in Regulatory Affairs within a pharmaceutical organization. Be specific about your interactions with Global Health Authorities and any relevant submissions you've managed.
Showcase Your Skills: Make sure to highlight your technical knowledge and ability to assess regulatory compliance. If you have experience advocating for regulatory initiatives, include examples that demonstrate your persuasive communication skills.
Tailor Your Application: Customize your application materials to reflect GSK's values and mission. Mention how your personal goals align with their purpose of uniting science, technology, and talent to get ahead of disease together.
How to prepare for a job interview at ENGINEERINGUK
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of the current regulatory environment in the pharmaceutical industry. Familiarize yourself with GSK's specific processes and policies, as well as regional regulatory requirements that may impact your role.
✨Showcase Your Strategic Thinking
Be prepared to discuss how you would develop and execute a regional regulatory strategy. Highlight your experience in planning over multiple years and how you can align local needs with global objectives.
✨Demonstrate Your Advocacy Skills
Since the role involves advocating for regulatory strategies, be ready to provide examples of how you've successfully influenced senior leaders or regulatory officials in the past. This will show your ability to navigate complex interactions.
✨Prepare for Technical Questions
Expect questions that assess your technical knowledge in regulatory compliance. Brush up on your understanding of the drug development process and be ready to discuss how you would evaluate potential in-license molecules.
