Strategy Lead, CMC Mature, Regulatory Affairs

GSK

USA - Maryland - Rockville +3 more Onsite Regulatory Affairs Management

About this role

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.
Find out more:
Our approach to R&D

Position Summary
You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects 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 offers visible influence on product life cycles, opportunities for professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

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 Qualification

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

Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field (advanced degree preferred).
2+ 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.
CMC experience for biologics, including regulatory requirements and technical content for submissions.
Comprehensive understanding FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics.
Experience global CMC regulatory requirements and drug development processes.
Experience with reviewing and preparing CMC submission components, particularly eCTD Module 3
Experience with manufacturing processes for biologics, including formulation, quality control, and analytical methods.
Experience translating technical and scientific information into clear, concise regulatory submissions.
Experience with mature product lifecycle management and post-approval changes.

Preferred Qualification
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.
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.
Proven ability to collaborate with cross-functional teams including quality, manufacturing and clinical development.
Strong written and verbal communication skills.

Working model
This role is hybrid. You will be expected to be on-site regularly and collaborate with colleagues across sites and regions.

#GSK-LI

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $113,850 to $189,750. 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, the relevant compensation will be discussed during the recruitment process.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

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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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/