Global Regulatory Affairs Manager, Open to flexible working
7 days left
- Contract Type
Global Regulatory Affairs Manager Therapeutic Group Classic & Established Products
We are recruiting for a talented Regulatory Manager with strong global regulatory affairs knowledge/experience and interpersonal skills to join our Classic & Established Products Therapeutic Group, Global Regulatory Affairs team in West London, UK, leading the regulatory strategies for our marketed products in life cycle management.
As part of our integrated Global Regulatory Affairs organization you will focus on developing and driving innovative global regulatory strategies that maximise the value of GSK’s fast-paced and exciting portfolio of marketed products, some of which have been in the market for several decades but are still providing a positive impact on the lives of our patients in Europe, China, Japan and Emerging markets. If you are passionate about making a difference, this could be the role for you!
About the role
The role offers a great opportunity to join a collaborative and supportive team in a challenging and rewarding role. This will require close collaboration with colleagues across the Regulatory matrix, as well as with our Medical, Safety, Commercial and Manufacturing colleagues to ensure:
- The development of regulatory strategy(s) (excluding US) and their execution for assigned asset(s) consistent with the strategic activities for GSK’s marketed product portfolio.
- Compliance with both internal GSK process / policy and with regional regulatory requirements
Location: GSK house, West London with flexibility to work part of the week from home.
Responsibilities and Accountabilities:
Accountable to the CEP Therapeutic Group Head for development of appropriate 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.
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
Competencies and Capabilities
- Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion.
- Able to foster strong matrix working. Capable of developing and recommending strategies for change.
- Strong skills developing personal networks 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 make sound decisions.
- 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
Experience, Skills and Specialised Knowledge:
- Bachelor’s degree in life sciences
- 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.
- Recent experience developing regulatory strategies for established products requiring clinical development (e.g. early post-marketing setting, paediatrics, ahead of loss of exclusivity)
- 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
Closing Date for Applications: 10th December 2021 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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 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.
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