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

Business Introduction
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.
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Our approach to R&D

Position Summary

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.

Key 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.

Why You?

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• 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.

What we offer in this role
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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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