Regulatory Affairs Director - Established Products

GlaxoSmithKline; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

Join a forward-thinking biopharma company as a Regulatory Director, where you will play a crucial role in developing regional regulatory strategies for innovative products. This position offers the chance to lead cross-functional teams and engage with regulatory authorities, ensuring compliance and advocating for the best outcomes for patients. With a commitment to scientific advancement and a supportive work environment, this role promises not only professional growth but also the opportunity to make a significant impact in the healthcare sector. If you're ready to contribute to a mission that prioritizes health and well-being, this is the perfect opportunity for you.

Qualifications

• 5+ years of regulatory affairs experience in the industry.
• Experience leading matrixed teams across global regions.

Responsibilities

• Develop and execute regional regulatory strategies for assigned assets.
• Lead interactions with local and regional regulatory authorities.

Skills

Regulatory Affairs

Leadership

Communication

Strategic Planning

Advocacy

Education

Bachelor’s degree

PhD or Master’s degree in life sciences or pharmacy

Job description

Site Name: UK – London – New Oxford Street
Posted Date: Apr 28 2025

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 both internal GSK process / policy and with regional regulatory requirements.

Key Responsibilities

Accountable to the Senior/Executive Director 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
• 5 or more years industry regulatory affairs experience
• 5 or more years leading matrixed teams across global regions

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
• Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
• Proven experience of leading regional development, submission and approval activities in local region(s).
• Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
• Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
• Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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