Director of Regulatory Policy and Advocacy

4 days ago


Collegeville, Pennsylvania, United States 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 CMC regulatory strategies to influence CMC policies and guidelines.
  • Engage with regulatory agencies, industry groups, and other stakeholders to advocate for favorable regulatory environments.
  • Monitor and analyze CMC regulatory trends, providing strategic insights to internal teams.
  • Lead cross-functional teams to ensure compliance with global CMC regulatory requirements and implement innovative CMC strategies.
  • Represent the company in industry forums, conferences, and regulatory meetings.
  • Collaborate with internal departments to align regulatory strategies with business objectives.
Qualifications
  • Advanced degree in a scientific discipline (Ph.D., Pharm.D., or equivalent preferred).
  • Experience of CMC within the biopharmaceutical industry.
  • Strong knowledge of global CMC regulatory requirements and guidelines.
  • Excellent communication, negotiation, and advocacy skills.
  • Proven ability to build and maintain relationships with regulatory authorities and industry stakeholders.
  • Strategic thinker with the ability to influence and drive regulatory policy changes.
About GlaxoSmithKline

GlaxoSmithKline is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus 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).

We are committed to creating a workplace where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.



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