Director, Regulatory Policy and Advocacy

7 days ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
About the Role

We are seeking a highly experienced and motivated Director of Regulatory Policy and Advocacy to join our dynamic team at GlaxoSmithKline. This role will be pivotal in shaping and influencing regulatory policies related to Chemistry, Manufacturing, and Controls (CMC) on a global scale, with a particular focus on supporting our growing digital, devices, and sustainability priorities.

Key Responsibilities
  • Develop and Implement Regulatory Strategies: Develop and implement CMC regulatory strategies to influence CMC policies and guidelines, ensuring alignment with business objectives.
  • Advocate for Favourable Regulatory Environments: Engage with regulatory agencies, industry groups, and other stakeholders to advocate for favourable regulatory environments, leveraging strong advocacy skills and experience.
  • Monitor and Analyze Regulatory Trends: Monitor and analyze CMC regulatory trends, providing strategic insights to internal teams to inform regulatory strategies.
  • Lead Cross-Functional Teams: Lead cross-functional teams to ensure compliance with global CMC regulatory requirements and implement innovative CMC strategies, driving business growth and success.
  • Represent the Company: Represent the company in industry forums, conferences, and regulatory meetings, showcasing expertise and thought leadership.
  • Collaborate with Internal Departments: Collaborate with internal departments to align regulatory strategies with business objectives, ensuring seamless execution and delivery.
Qualifications
  • Advanced Degree: Advanced degree in a scientific discipline (Ph.D., Pharm.D., or equivalent preferred).
  • CMC Experience: Experience of CMC within the biopharmaceutical industry, with a strong understanding of global CMC regulatory requirements and guidelines.
  • Regulatory Knowledge: Strong knowledge of global CMC regulatory requirements and guidelines, with excellent communication, negotiation, and advocacy skills.
  • Relationship Building: Proven ability to build and maintain relationships with regulatory authorities and industry stakeholders, driving regulatory policy changes.
  • Strategic Thinking: Strategic thinker with the ability to influence and drive regulatory policy changes, ensuring business growth and success.
About GlaxoSmithKline

GlaxoSmithKline is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. We prevent and treat disease with vaccines, specialty, and general medicines, focusing on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

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