Global Regulatory Affairs - Associate Director/Manager, Open to flexible working

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
28 Jul 2021
Closes
22 Aug 2021
Ref
294330
Contract Type
Permanent

Global Regulatory Affairs - Associate Director/Manager, Specialty Therapeutic Group​

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 are looking for a talented Associate Director/Manager with strong global regulatory affairs knowledge/experience and interpersonal skills to join our GSK Specialty Therapeutic Group, Global Regulatory Affairs team in West London, UK. As a valued member of the Regulatory Matrix team(s) and the asset project team(s), you will be empowered to develop appropriate regional regulatory strategy(s) and ensure their execution for assigned asset(s), consistent with Medicines Development Strategy . With your strong regulatory expertise and communication/negotiation skills, you will provide regulatory strategic leadership and support for assigned asset(s) in the Pharmaceutical R&D portfolio and life cycle management, for regions outside US, with focus in EU, China, Japan and Emerging Markets.

About the role

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.

Responsibilities and Accountabilities

Accountable to Global Regulatory Lead and Global Regulatory Therapeutic Area Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. 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 local regulatory agencies. Work closely with local/regional commercial team to secure best possible labeling commensurate with the available data. Lead interactions with local/regional regulatory authorities. In performing the role, the job holder will be responsible for:

  • Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally
  • Implementation of the regional strategy(s) in support of the global project objectives
  • Lead regulatory interactions and the review processes in local region
  • Ensuring appropriate interaction with regional commercial teams in local region
  • Ensuring compliance with regional requirements at all stages of product life from Commit to Medicine Development to life cycle management

About you

Competencies and Capabilities

  • Strong oral and written communication skills. Capable of delivering key communications with clarity, impact and passion, tailored to the audience
  • Ability to foster strong matrix working. Involve people in issues that affect them. Facilitate dialogue between team and matrix members so they understand links between their different ideas and perspectives. Bring team members into the discussion so they can contribute their ideas. Capable of developing and recommending strategies for change. Developing personal networks within GSK and capable of using them to secure appropriate support and outcome for a project
  • Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognise potential long-term issues for projects
  • Ability to make sound decisions. In doing so, the job holder will use a range of sources and weigh benefits and risks before making important decisions
  • Show a constant focus on improving performance and excellence in all tasks. Challenge and question ways of working to seek improved process. Seek to raise levels of performance by establishing or improving process

Why you?

Experience, Skills and Specialised Knowledge

In addition to your regulatory expertise, the successful candidate will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative and leadership.

  • Bachelor degree or preferably PhD in biological or healthcare science
  • Experience in all phases of the drug development process and life cycle management in Regulatory Affairs
  • Ability to integrate regulatory science with scientific/clinical knowledge
  • Capable of leading regional development, submission and approval activities in local region(s), including regulatory interactions and negotiations
  • Extensive knowledge of clinical trial and licensing requirements in all major countries in the region outside the US, with focus on EU, China, Japan and Emerging Markets, and ideally knowledge of other key Agency processes in these regions
  • Knowledge of relevant area of medicine, and ability to further develop necessary specialist knowledge for the asset or area of medicine

Why GSK?

GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world.

We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.

We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations , it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day.

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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