Associate Director / Manager, Global Regulatory Affairs

    • Brentford, United Kingdom


We have announced recently that we are relocating all employees from Stockley Park to our headquarters, GSK House in Brentford, in Q2 and Q3 2020. We want to co-locate our teams and provide a modern fit-for-purpose working environment supporting GSK's Modern Employer ambition. While these roles will be based initially at Stockley Park, they will move to GSK House during Q2 or Q3 2020. We also offer flexible working arrangements with respect to working from home.

We have a fantastic opportunity for a talented Global Regulatory Affairs Associate Director/ Manager with strong regulatory affairs knowledge/experience to join our Therapeutic Group in West London. This represents an exciting opportunity to be part of GlaxoSmithKline (GSK) Pharmaceutical Research & Development (R&D), who is committed to innovative scientific research and discovery to help people do more, feel better, live longer.

In this role, you will provide regulatory strategicsupport forourearly and/or late stage Pharmaceutical R&D portfolio in the Specialty area. In Specialty, we are actively studying treatments for COVID-19, as well as a range of therapies for serious unmet needs in Respiratory, Rheumatology, GI, and Infectious Diseases.

Therapeutic Group, Global Regulatory Affairs
Our Global Regulatory Affairs (GRA) Therapeutic Group in Pharmaceutical R&D develops global regulatory strategies to deliver our innovative portfolio. We are strategic partners with other functions in R&D and Commercial in delivering and maintaining our product pipeline, whilst complying with Health Authority regulations. We share learnings and best practices to foster continuous improvement. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for GSK.

We operate by fostering strong global teamwork and building trusting relationships with internal and external partners, including Regulatory Agencies. We use our leadership, strategic thinking, smart risk-taking skills, global regulatory acumen, analytical ability, communication and influencing skills to advise our internal partners and negotiate with external stakeholders.
We believe in life-long learning and developing our people. We take ownership of our development, as driven by on-the-job experiences, interactions with people, formal instruction and access to learning resources, with support from our leaders.

Key Responsibilities include, but are not limited to:

  • Supporting the development of appropriate regional strategy and its execution consistent with the overall Medicines Development Strategy.
  • Acting as a key partner with the R&D and commercial teams and working closely with the broader regulatory matrix team to help conceive and deliver innovative regulatory strategies for assigned assets
  • Integrating aspects of strategic and operational regulatory affairs into asset development collaborating with the cross functional team including clinical research, biostatistics, nonclinical, CMC, diagnostics/device, etc.
  • Leading/supporting preparations and delivery of regional Health Authority interactions, clinical trial applications and marketing authorizations with the cross functional development and regulatory team
  • Proactively counsel teams and interpret health authority feedback, regulatory precedent, guidelines and policy to help drive the product strategy, as well as supporting efforts to shape the regulatory environment.

Why you?
To deliver in this role you will need to combine technical experience, as outlined below, with strong communication skills, both written and verbal. You will be capable of delivering key communications with clarity, impact and passion. You will have strong negotiation skills and will be able to apply these across all levels within the organisation and with external stakeholders, including regulatory agencies. You will be a multi-tasker, who can balance multiple projects simultaneously and proactively plan your work, and the work of project teams, for the most successful results.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelors or advanced degree in appropriate scientific or clinical discipline
  • Capable of leading regional development, submission and approval activities in local regions, including leading some local health authority interactions
  • Knowledge of clinical trial and marketing authorization in all major countries in the region and ideally knowledge of other key Agency processes globally.
  • Demonstrated ability to think strategically and integrate regulatory science with scientific/clinical knowledge.
  • Demonstrated ability to foster strong matrix team working in a global team environment

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's Degree or PhD (or equivalent)
  • Global regulatory experience
  • Experience of all phases of the drug development process in regulatory affairs


Why GSK?

At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses (Pharmaceuticals, Vaccines & Consumer Health) research and deliver innovative medicines, vaccines and consumer healthcare products. We are committed to overcoming some of the biggest challenges in global health; delivering products of value in a responsible, sustainable way; and providing access to medicine for the world's poorest communities.
In Pharmaceuticals, our approach to R&D focuses on science related to the immune system, and the use of genetics and investments in advanced technologies (view video to learn more about our strategy) . We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

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

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).

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.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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 GSK's Transparency Reporting For the Record site.


Back to top