We are seeking a highly experienced and motivated Director of CMC Regulatory Policy and Advocacy to join our dynamic team. 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. The candidate will have a deep understanding of CMC regulatory frameworks and manufacturing with strong advocacy skills, experience with networking and a proven track record in the biopharmaceutical industry. The ideal candidate will have outstanding communication skills, and a future-facing focus on innovation.

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 favourable 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK 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 – as an organisation where people can thrive. 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).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place 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. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. 

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