Regulatory Affairs Associate Director, Established Products, London, England, United Kingdom

Regulatory Affairs Associate Director, Established Products

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Site Name: UK – London – New Oxford Street, UK - Hertfordshire - Stevenage

Posted Date: Jul 22 2025

Job Purpose

Ensure the development of appropriate global and/or regional regulatory life-cycle strategy(s) and their execution for assigned products to meet the needs of the business. This goal has to be achieved whilst ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible life cycle management and expansion commensurate with the available data, and through optimum life cycle maintenance support.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

Proactively develop regulatory life-cycle strategy that 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 global regulatory life-cycle strategy.
Lead regulatory interactions and the review processes in local region.
Ensure effective partnerships with stakeholders and senior leaders across GRA, safety, global medical and commercial teams and local regulatory counterparts in key markets.
Ensure compliance with global/ regional requirements and delivery of unfulfilled regulatory commitments.
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for a product

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

BSc in Biological or Healthcare Science
Experience of life-cycle management including clinical line extensions of the drug development process in regulatory affairs
Capable of leading regional life-cycle expansion strategies and delivering submission and approval activities in local region(s)
Knowledge of clinical trial and life-cycle management licensing requirements in key markets in the region and ideally knowledge of other key Agency processes globally.
Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or therapy area.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

PhD in Biological or Healthcare Science
Experience in respiratory therapy area

Closing Date for Applications – 5th of August 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Seniority level

Seniority level
Not Applicable

Employment type

Employment type
Full-time

Job function

Job function
Legal
Industries
Pharmaceutical Manufacturing

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Location:: London, England, United Kingdom
Salary:: £200,000 +
Job Type:: FullTime
Category:: Management & Operations

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