GSK
Overview
CMC Mature Projects Regulatory Senior Manager / role at GSK. This role leads and delivers Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines, managing global CMC regulatory activities across development, registration, and lifecycle management. Collaboration with cross-functional teams is essential to ensure compliance and drive innovation. Candidates should be proactive, detail-oriented, and adept 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 (R&D, manufacturing, quality assurance) to ensure compliance with U.S. regulatory requirements, including GMPs. Serve as point of contact for the FDA to receive and respond to inquiries, notifications, and information requests, and lead discussions in formal meetings 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. Basic Qualifications
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. Preferred Skills & Qualifications
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 with FDA representatives and internal stakeholders. Ability to translate technical and scientific information into clear, concise regulatory submissions. Ability to coordinate cross-functional teams to gather and compile submission data. Organizational and Problem-Solving Skills
Strong organizational skills to manage multiple CMC submissions and meet deadlines. Ability to manage multiple projects while maintaining regulatory compliance. 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. Salary and Benefits:
The US annual base salary ranges from $144,375 to $240,625, with additional bonus eligibility and a long-term incentive program. Benefits include health care, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Salary details may vary by country/location and will be discussed during recruitment if not displayed. Why GSK?
GSK is a global biopharma company dedicated to uniting science, technology and talent to get ahead of disease together. We are committed to creating an environment where our people can thrive and focus on what matters most. We value a culture of ambition for patients, accountability for impact, and integrity. If you require accommodation or assistance to apply, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. We prohibit discrimination based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service, or any other basis prohibited by law.
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CMC Mature Projects Regulatory Senior Manager / role at GSK. This role leads and delivers Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines, managing global CMC regulatory activities across development, registration, and lifecycle management. Collaboration with cross-functional teams is essential to ensure compliance and drive innovation. Candidates should be proactive, detail-oriented, and adept 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 (R&D, manufacturing, quality assurance) to ensure compliance with U.S. regulatory requirements, including GMPs. Serve as point of contact for the FDA to receive and respond to inquiries, notifications, and information requests, and lead discussions in formal meetings 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. Basic Qualifications
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. Preferred Skills & Qualifications
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 with FDA representatives and internal stakeholders. Ability to translate technical and scientific information into clear, concise regulatory submissions. Ability to coordinate cross-functional teams to gather and compile submission data. Organizational and Problem-Solving Skills
Strong organizational skills to manage multiple CMC submissions and meet deadlines. Ability to manage multiple projects while maintaining regulatory compliance. 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. Salary and Benefits:
The US annual base salary ranges from $144,375 to $240,625, with additional bonus eligibility and a long-term incentive program. Benefits include health care, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Salary details may vary by country/location and will be discussed during recruitment if not displayed. Why GSK?
GSK is a global biopharma company dedicated to uniting science, technology and talent to get ahead of disease together. We are committed to creating an environment where our people can thrive and focus on what matters most. We value a culture of ambition for patients, accountability for impact, and integrity. If you require accommodation or assistance to apply, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. We prohibit discrimination based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service, or any other basis prohibited by law.
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