Regional Regulatory Affairs Director – International
GSK · Sienne
Description du poste
About the role
GSK is seeking a Regional Regulatory Affairs Director to lead the development and execution of a high‑quality, business‑focused regulatory strategy for assigned assets across multiple countries. The role works closely with Global Regulatory Leads, Local Operating Company Regulatory Affairs, and regional medical and commercial teams to ensure alignment with enterprise goals and regional requirements.
Key responsibilities
- Define and deliver optimal regional regulatory strategy on a multi‑year horizon, coordinating with senior leadership across the organization.
- Act as the single point of contact for the region, liaising between Global Regulatory Leads, Medical, Commercial, and Local Regulatory teams.
- Provide deep regulatory knowledge of international markets and therapeutic areas to anticipate risks and opportunities.
- Assess regulatory intelligence, precedent, and competitive landscape to translate updates into actionable insights.
- Develop and implement regional regulatory plans that comply with local regulations and GSK policies.
- Represent the Regulatory function in regional stakeholder meetings to ensure timely alignment on strategy and priorities.
Required profile
- Extensive experience in regulatory affairs within the pharmaceutical or biotech industry.
- Proven ability to work within complex stakeholder matrices at senior levels.
- Strong understanding of regional regulatory requirements and acceleration opportunities.
- Excellent communication and influencing skills across global and local teams.
Required skills
- Regulatory strategy development
- Regulatory intelligence analysis
- Cross‑functional collaboration
- Knowledge of therapeutic area regulations
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Sienne
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