Sr. Director​/Director Biopharm CMC Strategy, Policy and Advocacy

Site Name: Upper Providence, Washington DC

Posted Date: Jan 19 2026

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

We’re uniting science, technology, and talent to get ahead of disease together.

Find out more:
Our approach to R&D

We are seeking a highly experienced and motivated Sr. Director/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 in manufacturing and CMC.

• Develop and implement CMC regulatory strategies to influence CMC policies and guidelines, with a focus on the US.
• Engage with regulatory agencies, industry groups, and other stakeholders to advocate for a CMC regulatory environment enabling innovation and patient access.
• Monitor and analyze CMC trends, providing strategic CMC regulatory insights to internal teams.
• Lead cross‑functional business 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 CMC regulatory strategies with business objectives and delivery of the innovative medicines pipeline.

• Advanced degree in a scientific discipline (Ph.D., Pharm.
  
  D., or equivalent preferred).
• Minimum of 10 (12+ for Sr Director) years of 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.
• Experience of developing a policy and intelligence network, with a focus on the US.
• Strategic thinker with the ability to influence and drive CMC regulatory policy changes.

You will join a collaborative and mission‑driven team. Your work will directly influence the regulatory environment and help bring safe, effective biopharmaceuticals to patients sooner. You will have opportunities to grow your leadership skills, broaden your external network, and shape policy at national and global levels.

Apply now if you are ready to lead CMC strategy and advocacy that makes a real difference for patients and for GSK. We look forward to hearing how your experience can help us get ahead of disease together.

The US annual base salary for new hires in this position ranges from $193,500 to $322,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.

Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

If salary ranges are not displayed in the job posting for a specific country,…