Senior Manager, Global Regulatory Affairs

JR United Kingdom; Oxford; On-site; GBP 60,000 - 80,000; Full time

Job summary

Une entreprise biopharmaceutique mondiale recherche un Senior Manager en Affaires Réglementaires pour son équipe. Le poste nécessite plus de 5 ans d'expérience et implique la gestion de soumissions réglementaires pour des marchés internationaux. Le candidat idéal aura une forte expérience en affaires réglementaires, en particulier dans les marchés émergents, et sera capable de collaborer efficacement avec des équipes interfonctionnelles à l'échelle mondiale.

Qualifications

• Minimum de 5 ans d'expérience dans l'industrie pharmaceutique ou biotechnologique.
• Capacité prouvée à représenter la région sur des équipes de projet interfonctionnelles.
• Expérience démontrée dans la préparation de soumissions NDA.

Responsibilities

• Jouer un rôle stratégique dans les stratégies de soumission et assurer la conformité.
• Collaborer avec des parties prenantes mondiales sur des projets.
• Contribuer à l'accès à la santé dans les régions sous-desservies.

Skills

Regulatory Affairs

Cross-functional collaboration

Understanding of international regulatory requirements

Job description

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Senior Manager, Global Regulatory Affairs, oxford district

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Client:

Planet Pharma

Location:

oxford district, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

04.06.2025

Expiry Date:

19.07.2025

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Job Description:

Planet Pharma is currently working on an exciting opportunity with a global biopharmaceutical company that’s looking to expand its Regulatory Affairs team. The role focuses on International Growth Markets, supporting the lifecycle management of key marketed products.

As a key member of the global regulatory project team, you’d play a strategic role in shaping submission strategies and ensuring compliance across diverse markets. If you have 3–5+ years’ experience in regulatory affairs, particularly in emerging markets, and enjoy cross-functional collaboration with global stakeholders, this could be a fantastic next step.

Requirements:

• Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with a focus on Regulatory Affairs—preferably within International or Emerging Markets.
• Proven ability to effectively represent the region and the International/Global Markets (IGM) group on cross-functional project teams.
• Demonstrated experience in preparing New Drug Application (NDA) submissions for countries within the IGM region.
• Strong understanding of international regulatory requirements and processes.

The position offers a truly international scope, high visibility, and the chance to contribute to meaningful healthcare access across underserved regions.

For more information or to apply, please contact Ollie at Planet Pharma at [emailprotected]