Regulatory Manager- Established Products, Open to flexible working

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
19 May 2021
Closes
18 Jun 2021
Ref
289764
Contract Type
Permanent

Ensure the development of regulatory strategy(s) (excluding US) and their execution for assigned asset(s) consistent with the strategic activities for GSK's Classic & Established Product (CEP) portfolio. Ensure compliance with both internal GSK process / policy and with regional regulatory requirements.

Key Responsibilities:

Reporting to the Senior Director Therapeutic Group CEP.

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 regulatory agencies, including directly with the European Medicines Agency for centralised approved products. Work closely with partner functions to secure / maintain best possible labelling commensurate with the available data. Work with local regulatory function to (co)- lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for:

  • Ensuring the regulatory strategy 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
  • Ensuring appropriate interaction with regional and CEP commercial teams
  • Ensuring compliance with regional regulatory requirements

Why you?

Basic Qualifications:

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

  • Bachelor's degree or preferably PhD in biological or healthcare science
  • Experience of all phases of the drug development process in regulatory affairs, with particular emphasis on maintenance and lifecycle management of marketed products, including for projects with little or no precedence.
  • Capable of leading regional regulatory strategy development, submission and approval activities in local region(s).
  • Extensive knowledge of licensing requirements in all major countries in the region and knowledge of other key Agency processes.
  • Capable of being able to develop product / therapeutic knowledge in new area

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion
  • Able 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. 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 propose creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises and escalates potential long-term issues for projects/products
  • Ability to take sound decisions. In doing so use a range of sources and weigh benefits and risks before making important decisions, seeking support and endorsement as necessary.
  • Shows a consistent focus on compliance and seeking to deliver and perform with 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

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.

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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