Global Regulatory Affairs Manager, Open to flexible working

Location
Brentford, Stevenage
Salary
£Competitive
Posted
06 Jan 2021
Closes
31 Jan 2021
Ref
273968
Contract Type
Permanent

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 (include expected deliverables, managerial and leadership responsibilities and performance standards)

Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. 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 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 in to account the needs of other regions globally
  • Implementation of the regional strategy(s) in support of the project globally
  • 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 C2MD

Competencies and Capabilities (include key high performance behaviours)

  • Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion
  • Ability to foster strong matrix working. Involves people in issues that affect them. Facilitates dialogue between team and matrix members so they understand links between their different ideas and perspectives. Brings 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. Recognises potential long term issues for projects.
  • Ability to take sound decisions In doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions.
  • Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process

Experience, Skills and Specialized Knowledge Required (include required and preferred education and experience)

  • Bachelor degree or preferably PhD in biological or healthcare science
  • Experience of all phases of the drug development process in regulatory affairs,
  • Capable of leading regional development, submission and approval activities in local region(s)
  • Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
  • Knowledge of relevant area of medicine, and ability to further develop necessary specialist knowledge for the product or area of medicine

Why GSK?

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

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. 

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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