Site Name: UK – London – New Oxford Street, Belgium-Wavre, Poznan Grunwaldzka, Siena
Posted Date: Jul 15 2025
Job Purpose
The Executive Director, Head of European Local Operating Company (LOC) and Regional Reliance Lead resides in the Regional Regulatory Affairs (RRA) organization and is responsible to drive the strategic agenda for the Regulatory Affairs Function in Tier 1, Tier 2 LOCs and cluster markets, in support of the European Commercial business, for initial and lifecycle submissions for all therapeutic areas within the GSK Portfolio. In addition, the role will be the Reliance Lead for Regional Regulatory Affairs, in close partnership with the Therapeutic Areas, CMC RA and the Regional commercial organization. The position will contribute to growth and profitability of GSK business, to protect reputation and ensure regulatory compliance in the region in alignment with GSK Regulatory Affairs objectives, policies and standards as well as with the regional commercial objectives. The position is a key member of the Regional Regulatory Affairs leadership team, the EU Commercial Leadership Team and interacts with the EU LOCs on an ongoing basis.
In view of the increasing importance of Reliance procedures in the Regional Regulatory Affairs organization and in order to accelerate Major Submissions and consequentially, patient access across the regions, the job holder will lead and take accountability to develop an optimized process for reliance procedures (ORBIS and ACCESS and any other reliance procedures), ensure it is rolled out and consistently applied across our portfolio and countries and remain the Business Lead for this process subsequently.
Key Responsibilities
- Leads a premier European Regulatory Affairs LOC RA team, with focus on a streamlined and aligned way of working across the countries and clusters and for stakeholders.
- As a member of the RRA leadership team, participates in setting strategic and operational direction for the local regulatory affairs organization
- Aligns goals and objectives with TGs and commercial organizations; ensure harmonized approach for input into product development, compliance, training, career development, etc.
- Actively shapes and contributes to the European business as a strategic member of the EU Commercial LT and via LOC GM/CMD and supply interactions.
- Accelerates Major Submissions in specific countries across all regions, lead and take accountability to develop an optimized process related to reliance procedures (ORBIS and ACCESS and any other reliance procedures), ensure it is rolled out and consistently applied across our portfolio and countries and remain the Business Lead for this process subsequently.
- Provide line management, supervision and coaching of LOC RA staff in organization, ensure staff are knowledgeable and provided with appropriate technical/therapeutic area training
- Develop and execute an inclusive talent strategy to ensure optimal talent development, build a pipeline of future regulatory leaders; Support, mentor and foster talent development.
- Develop and deploy metrics to benchmark performance
- Provide oversight and guidance on the implementation of regulatory strategies and regulatory submission plans for European markets, in line with R&D, regional and local business objectives, for the entire GSK portfolio
- Provide guidance to staff in developing options to manage risks and overcome barriers
- Ensure that submission tactical plans and timelines are negotiated with and communicated to global, regional and local stakeholders
- Align appropriate resources, professional development and succession planning as well as performance assessment of the LOC Regulatory staff with Regional Commercial SVP and General Managers;
- Maintain excellent relationships with senior business partners including GM / LOC, Commercial, Medical, Supply Chain, Quality, to drive performance and maintain trust;
- Provide input into the LOC Regulatory budget as needed;
- Support preparations for meetings with Health Authorities as appropriate, along with relevant GRA groups (Global TAs, CMC RA).
- Collaborate extensively across all regions, with all key GRA stakeholders and Commercial partners to develop and implement the optimal approach.
- Shape the regulatory environment through active engagement with local HAs and Trade Association etc
- Facilitate and support leading roles of cluster/local RA leaders in industry associations
- Works closely with the EU Regulatory Policy & Intelligence team to monitor, assess and communicate the changing regulatory environment, existing legislations and guidelines on clinical development plans and registration strategy
- Ensure appropriate advocacy strategies are in place to shape evolving legislation / regulatory requirements in partnership with relevant experts. Advances GSK advocacy initiatives through external networks e.g. trade associations
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree
- Experience in pharmaceutical industry
- Relevant industry experience in Regulatory Affairs of which a considerable part has been in a senior role in multinational companies leading above country regulatory function
- Local ground operations background (added advantage)
- Experience of working effectively in a matrix across functions
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Master degree or PhD or equivalent
- Extensive knowledge of drug development
- Ability to effectively influence key stakeholders at all levels of the organization
- Consulting/advisory experience at senior management level
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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