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

3 days left

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
29 Apr 2022
Closes
20 May 2022
Ref
331770
Contract Type
Permanent

As a Global Regulatory Affairs Manager/Associate Director, you will be a member of the Regulatory Matrix Team (RMT) led by the Global Regulatory Lead (GRL) and you will be responsible for the development and execution of regulatory strategies for assigned asset(s) in line with the Global Medicines Development Strategy and in compliance with both internal GSK processes / policy and with regional regulatory requirements.

You will also be responsible for representing GSK in interactions with local/regional regulatory authorities.

Your Responsibilities:

  • Provide the regional regulatory strategy and requirements in line with the global strategy
  • Drive the implementation of the regional strategy(s)
  • Lead regulatory interactions and the review processes in the region
  • Ensure appropriate interaction with the regional commercial team

Your Skills:

  • Capable of delivering key communications with clarity and impact
  • Able to thrive in a matrix environment and engage with team members within the cross-functional matrix to drive decisions
  • Be proactive in identifying potential issues in advance and seeking resolution.
  • Able to derive sound solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
  • Focused on improving performance and excellence in all tasks by challenging ways of working to seek improved processes

Your Qualifications and Experience:

  • Bachelor degree or preferably PhD in biological or healthcare science
  • Experience of different phases of the drug development process in regulatory affairs
  • Experience of contributing to regional development, submission and approval activities in at least one region
  • Ideally prior experience of working in oncology

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D,  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 specialty 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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