Executive Director, Global Regulatory Affairs, Head of European Local Operating Companies and Region

GSK; London; On-site; GBP 150,000 - 200,000; Full time

Job summary

A global biopharma company in London is seeking an Executive Director to lead the European Regulatory Affairs LOC team. The role includes aligning regulatory strategies with business goals, managing submissions, and ensuring compliance across therapeutic areas. The ideal candidate should have substantial experience in regulatory affairs within the pharmaceutical industry. This position offers an opportunity to significantly impact the company's growth and regulatory landscape.

Qualifications

• Experience in senior roles within multinational companies leading regulatory functions.
• Background in local ground operations is preferred.
• Experience working effectively in a matrix organization.

Responsibilities

• Lead a European Regulatory Affairs LOC RA team.
• Align goals with Therapeutic Groups and commercial organizations.
• Accelerate Major Submissions and oversee reliance procedures.

Skills

Experience in the pharmaceutical industry

Senior regulatory affairs experience

Ability to influence stakeholders

Education

Bachelor's degree

Master's degree, PhD, or equivalent (preferred)

Job description

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 for driving the strategic agenda for the Regulatory Affairs Function in Tier 1, Tier 2 LOCs, and cluster markets. The role supports the European Commercial business in initial and lifecycle submissions across all therapeutic areas within the GSK Portfolio. Additionally, the position will serve as the Reliance Lead for Regional Regulatory Affairs, working closely with Therapeutic Areas, CMC RA, and the Regional commercial organization. The role aims to contribute to GSK's growth and profitability, protect its reputation, and ensure regulatory compliance in the region, aligning with GSK Regulatory Affairs objectives, policies, standards, and regional commercial goals. The position is a key member of the Regional Regulatory Affairs leadership team, the EU Commercial Leadership Team, and maintains ongoing interaction with the EU LOCs.

Given the increasing importance of reliance procedures in the Regional Regulatory Affairs organization and the need to accelerate Major Submissions and patient access, the job holder will lead the development of an optimized reliance process (ORBIS, ACCESS, and others), ensure its rollout and consistent application across the portfolio and countries, and remain the Business Lead for this process.

Key Responsibilities

1. Lead a European Regulatory Affairs LOC RA team, focusing on streamlined and aligned operations across countries and stakeholders.
2. Participate in setting strategic and operational direction as a member of the RRA leadership team.
3. Align goals with Therapeutic Groups and commercial organizations; ensure harmonized approaches for product development, compliance, training, and career development.
4. Contribute to the European business strategy via the EU Commercial Leadership Team and interactions with LOC GM/CMD and supply chains.
5. Accelerate Major Submissions in specific countries, develop and implement reliance procedures (ORBIS, ACCESS), and oversee their application across portfolios and countries.
6. Manage, supervise, and coach LOC RA staff, ensuring they are knowledgeable and receive appropriate training.
7. Develop and implement talent strategies to foster regulatory leadership development.
8. Establish metrics to benchmark performance.
9. Oversee regulatory strategies and submission plans for European markets, aligned with R&D and regional objectives.
10. Guide staff in risk management and barrier resolution.
11. Negotiate and communicate submission plans and timelines with stakeholders.
12. Align resources, professional development, and performance assessments with regional leadership.
13. Maintain strong relationships with senior business partners to drive performance and trust.
14. Contribute to the LOC Regulatory budget as needed.
15. Support preparations for interactions with Health Authorities and relevant GRA groups.
16. Collaborate extensively across regions and stakeholders to develop and implement optimal approaches.
17. Engage with local health authorities and trade associations to shape the regulatory environment.
18. Support industry association leadership roles.
19. Work with the EU Regulatory Policy & Intelligence team to monitor and communicate regulatory changes and legislation.
20. Develop advocacy strategies to influence legislation and regulatory requirements, leveraging external networks.

Why you?

Basic Qualifications:

• Bachelor's degree
• Experience in the pharmaceutical industry
• Senior regulatory affairs experience in multinational companies, leading above-country functions
• Background in local ground operations (preferred)
• Experience working effectively in a matrix organization

Preferred Qualifications:

• Master's degree, PhD, or equivalent
• Extensive knowledge of drug development
• Ability to influence stakeholders at all levels
• Experience in consulting or advisory roles at senior management level

Why GSK?

GSK is a global biopharma company committed to uniting science, technology, and talent to combat disease. We focus on vaccines, specialty, and general medicines, investing in core therapeutic areas. Our success depends on our people, and we strive to create an inclusive environment where everyone can thrive. Join us to be part of this exciting journey to get Ahead Together.

GSK is an Equal Opportunity Employer and values diversity and inclusion.