Position Summary
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 part of an overall global regulatory approach while ensuring compliance with internal GSK process and policy and with regional regulatory requirements, delivering the best possible labeling in close collaboration with 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, as well as knowledge of the therapeutic area, to anticipate opportunities and risks to ensure 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, leveraging expertise, providing insights and guidance on specific local regulatory requirements and their implementation in the global strategy for effective planning (e.g. clinical studies & GMPc requirements, pre-submission activities, and submission prioritization based on regulatory requirements and commercial opportunities).
* Attain regulatory breakthroughs, evaluating the likelihood of regulatory success and developing risk mitigation measures.
* Lead the Regional Strategy in interactions between GRL and LOC RA to ensure that LOC regulatory input for regulatory strategy planning is provided on a timely basis; support operational and compliance activities for relevant assets, ensuring right dossier generation for the region and timely execution of regulatory submission plans, availability of regional marketing application dossier components, briefing packages, and timely responses to questions in collaboration with cross-functional SMEs, GRLs and LOCs.
* 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 elevate risks and issues related to regulatory strategy and supply disruption in 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.
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; experience organizing and executing successful milestone meetings and 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 a 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.
Work Arrangement
This role is based in London, Siena, Wavre (Belgium), or Poznan and is hybrid. Regular on-site collaboration is expected, typically two to three days on-site per week.
Benefits and Compensation
Salary ranges (gross) for new hires vary by location: Poland: PLN 410,250–683,750; Italy: EUR 86,250–143,750; Belgium: EUR 111,750–186,250. The role may also be eligible for an annual bonus and participation in a share‑based long‑term incentive program, depending on role level. Additional benefits may include private healthcare, paid days off, life insurance, private pension plan, and fully paid parental leave & care of family member leave.
Equal Opportunity Employment
GSK is an Equal Opportunity Employer. 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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