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

GSK • Washington DC, DC

15h

About The Position

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.

Requirements

• 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.
• Strategic thinker with the ability to influence and drive CMC regulatory policy changes.

Nice To Haves

• Experience of developing a policy and intelligence network, with a focus on the US

Responsibilities

• 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.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees