Global Regulatory Affairs - Director, Speciality Therapeutic Group - Flexible & Hybrid Working
Are you a Regulatory Affairs expert looking for an exciting opportunity to develop your career and advance your personal development journey within an innovative, collaborative, inclusive and diverse Research and Development organisation? Then this role could be for you!
We have a fantastic opportunity for a talented Director with extensive global regulatory affairs knowledge / experience and excellent interpersonal skills to join our GSK Speciality Therapeutic Group, Global Regulatory Affairs team in West London, UK.
We are open to remote working for this role with some travel to GSK House preferred.
As a valued lead or member of the Regulatory Matrix team(s) and the asset project team(s), you will be empowered to develop and lead appropriate global/regional regulatory strategy(s) and ensure their execution for assigned asset(s), consistent with the Medicines Development Strategy. With your innovative approach, extensive regulatory expertise, and strong communication/negotiation skills, you will provide global regulatory strategic leadership and support for early and/or late-stage Pharmaceutical R&D portfolio and life cycle management. In conducting this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with regulatory agencies.
In this role you will…
- Act as an empowered Global Regulatory Lead and/or Regional Lead for assigned assets, accountable to Global Regulatory Therapeutic Area and/or Global Regulatory Lead.
- Serve as a key strategic partner with the Pharmaceutical R&D and Commercial teams and work closely with the broader Regulatory Matrix Team to conceive and deliver innovative regulatory strategies for assigned assets.
- Integrate aspects of strategic and operational Regulatory Affairs into asset development, collaborating with the cross functional team including Clinical Research, Biostatistics, Nonclinical, CMC, Diagnostics/Device, Commercial, etc
- Lead preparations and delivery of health authority interactions with the cross functional central team and the development and regulatory teams in the local regions.
- Prepare and/or co-ordinate regulatory documentation to support early phase development which may include agency briefing documents, orphan drug applications, clinical trial applications, amendments, and pediatric investigation plans. Ensure appropriate interactions with global/regional counterparts and commercial teams in local regions in these activities.
- Proactively counsel teams, and interpret health authority feedback, regulatory precedent, guidelines, and policy to drive the medicine strategy, as well as driving or supporting efforts to shape the regulatory environment
Qualifications & Skills:
- Bachelor’s degree in biological or healthcare science
- Extensive global regulatory experience in all phases of drug development and life cycle management in Regulatory Affairs, including EU, US, Japan, and China Regulatory Strategy including developing and implementing regulatory strategy
- Ability to integrate regulatory science with scientific/clinical knowledge. Capable of leading global development, submission and approval activities including regulatory interactions and negotiations with major health authorities
- Extensive knowledge of clinical trial and licensing requirements in all major countries including US, EU, China, Japan, and Emerging Markets and ideally knowledge of other key Agency processes in these regions
- Knowledge of relevant therapy area, experience with biologics, and ability to further develop necessary specialist knowledge for the asset or area of medicine
- Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations in all regions.
- Demonstrated track record of working in cross company collaborations, in a global team and matrix organization and with strategic partners
- Demonstrated leadership capabilities and ability to think strategically.
- Strong written and verbal communications skills
- Excellent negotiation skills across levels within an organisation and with external stakeholders
- Able to manage multiple projects and proactively plan
- Highly motivated and able to work independently with limited supervision
Preferred Qualifications & Skills:
- PhD degree in biological or healthcare science.
- Experience in partnering with business development in due diligence efforts.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and speciality medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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.
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.
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