CMC Mature Products Regulatory Senior Manager

Position Summary:

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you'll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments.

This role is based in the US at one of these locations: Rockville, MD, Upper Merion, PA or Durham, NC. 2-3 days on-site per week average presence is required.

Responsibilities:

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with FDA expectations and global standards.
• Prepare and review technical regulatory documents to submit to regulatory authorities, including the FDA, to support lifecycle management of established vaccines.
• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance to ensure compliance with U.S. regulatory requirements, including Good Manufacturing Practices (GMPs).
• Serve as Point of Contact for the FDA to receive and respond to general inquiries, notifications, and requests for information, as well as to lead discussions in formal meetings and other engagements with the Agency.
• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members, fostering a culture of continuous improvement.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in life sciences, pharmacy, chemistry, or a related field .
• 6+ years of experience in CMC regulatory affairs, with a focus on IND and BLA submissions to the FDA.
• Experience as a liaison for FDA communications.
• Experience with FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics.

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

• Master's degree or PhD in a relevant scientific discipline.
• Regulatory Affairs Certification (e.g., RAPS).
• Experience leading teams and managing complex regulatory submissions.
• Track record of effective negotiation with regulatory agencies.
  

Regulatory and Technical Expertise:

• In-depth knowledge of CMC for biologics, including regulatory requirements and technical content for submissions.
• Strong knowledge of global CMC regulatory requirements and drug development processes.
• Proficiency in reviewing and preparing CMC submission components, particularly eCTD Module 3
• Strong understanding of manufacturing processes for biologics, including formulation, quality control, and analytical methods.

Communication and Collaboration:

• Fluency in English with excellent verbal and written communication skills to interact effectively with FDA representatives and internal stakeholders.
• Proven ability to translate technical and scientific information into clear, concise regulatory submissions.
• Ability to coordinate cross-functional teams (e.g., manufacturing, quality, R&D, regulatory) to gather and compile submission data.

Organizational and Problem-Solving Skills:

• Strong organizational skills to manage multiple CMC submissions and meet strict deadlines.
• Proven ability to manage multiple projects while maintaining compliance with regulatory requirements.
• Strong attention to detail to ensure accuracy and completeness of CMC documentation.
• Ability to identify and resolve gaps or inconsistencies in regulatory submissions proactively.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

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.

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