Job Description
Lead the development of appropriate business-focused, high‑quality, timely regional regulatory strategy and its execution for assigned asset(s), consistent with relevant enterprise goals and respective product profile. This goal is achieved as a component of an overall global regulatory approach while ensuring compliance with both internal GSK process/policy and with regional regulatory requirements to deliver the best possible labeling in close collaboration and alignment with respective Global Regulatory Lead (GRL), Local Operating Company Regulatory Affairs (LOC RA) and Regional Medical & Commercial Leads.
Key Responsibilities
- Provide deep regulatory knowledge and international markets expertise to anticipate opportunities and risks, ensuring seamless regional integration into global regulatory strategy.
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact on the regional regulatory strategy, converting regulatory updates into actionable insights.
- Proactively develop and implement regional regulatory strategy aligned with enterprise goals and local opportunities, in compliance with local requirements and GSK policies.
- Represent Regulatory function in collaboration with regional stakeholders, fostering timely alignment with the regional team on strategies and priorities and emerging business opportunities prior to and during enterprise formal governances.
- Represent Regional Regulatory function in global forums and cross‑functional collaboration to advocate regional business position and address region specificities, supporting resource planning at global level.
- Serve as single point of contact for regional regulatory to GRLs in global initiatives and work with GRL to ensure alignment with V/MDT and PALT prior to R&D Governance.
- Contribute to the development of Global Regulatory Strategy (GRS) ensuring alignment with core product labeling and regional regulatory requirements.
- Drive early engagement with LOC RAs proactively sharing knowledge on clinical development programs and key project milestones, equipping local teams to partner in local launch readiness discussions.
- Collaborate with GRL and LOC RA at early stages of development, providing expertise and guidance on specific local regulatory requirements and their implementation in the global strategy.
- Attain regulatory breakthroughs, evaluating likelihood of regulatory success and developing risk mitigation measures.
- Lead the Regional Strategy in interactions between GRL and LOC RA to ensure timely regulatory input, support operational and compliance activities, ensure right dossier generation, timely execution of submission plans, and responsive communication.
- Seek processes optimization opportunities, sharing learnings and best practices across the teams.
- Proceed with appropriate handovers to relevant areas after regulatory approval milestones are reached to ensure flawless execution of planned strategy and launch readiness.
- Accountable for complete, accurate, and timely communication on the relevant assets’ key milestones, translating high‑level program updates into actionable insights and strategic implications for the region.
- Anticipate and escalation of risks and issues related to regulatory strategy and supply disruption in the region.
- Lead and implement regional innovation initiatives aligned to GRA objectives.
- Support continuous improvement for regulatory plans and act in mentorship of team members as required.
Qualifications
Basic Qualification
- Bachelor Degree in a scientific discipline such as life sciences, pharmacy, medicine, or equivalent.
- Proven experience of leading regional development, submission and approval activities in region(s) and/or globally, with a track record of successful relationships with one or more Health Authority.
- Extensive experience of all phases of the drug development process in regulatory affairs.
- Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
- Extensive knowledge of relevant areas of medicine, or proven track record of developing product/therapeutic knowledge in new area.
Preferred Qualification
- Advanced degree (Masters, PharmD, MD, or PhD) in a relevant scientific discipline.
- Direct experience in developmental regulatory strategy.
- Background in local operating company regulatory operations or labeling.
- Experience contributing to regulatory policy, advocacy, or interacting with regional health authorities.
- Track record of leading cross‑functional process improvements or portfolio prioritisation initiatives.
- Experience coaching and developing multi‑cultural teams.
Location & Benefits
Location: London, Siena, Wavre (Belgium), or Poznan. This role is hybrid with regular on‑site collaboration – typically two to three days on site per week.
Salary Range (Poland): PLN 410,250 – PLN 683,750 gross annually.
Italian Salary Range: EUR 86,250 – EUR 143,750.
Belgium Salary Range: EUR 111,750 – EUR 186,250.
Benefits include an annual bonus (if applicable), share‑based long‑term incentive program, private healthcare, additional paid days off, life insurance, private pension plan, fully paid parental leave and care of family member leave.
Equal Opportunity Employer
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, military service or any basis prohibited under federal, state or local law.
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