Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

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 activities across development, registration, and early lifecycle stages. You will work with cross-functional teams including development, manufacturing, quality, and regulatory colleagues. We value practical problem-solvers who communicate clearly, act with integrity, and put patients at the center. This role offers growth through complex regulatory work, direct impact on supply and access, and a chance to help 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 US and global filings and lifecycle maintenance. - Prepare, review and maintain CMC components of regulatory submissions and responses. - Provide clear regulatory advice to cross-functional teams on compliance, risk and readiness for submissions. - Lead agency interactions and act as a primary contact for regulatory authorities when required. - Support inspections, quality events and supply continuity through regulatory strategy and documentation. - Mentor colleagues and contribute to process improvements that raise quality and efficiency. 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, engineering or related field. - Minimum 6 years of CMC regulatory affairs experience in the pharmaceutical, biologics, or combination product space. - Experience preparing and authoring CMC dossier sections for US regulatory submissions. - Practical knowledge of US regulatory requirements, Good Manufacturing Practices, and relevant ICH guidance. - Proven ability to work in cross-functional teams and manage multiple projects to meet deadlines. - Strong written and verbal communication skills with experience communicating technical information clearly. Preferred Qualification If you have the following characteristics, it would be a plus - Advanced degree (Master’s or PhD) in a relevant scientific discipline. - Experience leading regulatory interactions with the US Food and Drug Administration. - Experience with eCTD Module 3 and managing complex submission packages. - Track record of supporting inspections or major quality events from a regulatory perspective. - Experience in device-related or combination product regulatory strategy. - Demonstrated ability to coach and develop junior regulatory colleagues. Location and Working Model - This role is based in the United States. Hybrid working is expected with regular on-site presence (typically 2-3 days per week), unless otherwise agreed with the hiring manager. What you will gain You will join a team focused on meaningful outcomes for patients. You will grow your technical and leadership skills through hands-on regulatory work. You will influence important decisions that support product quality and supply. We welcome people who bring different perspectives and who commit to an inclusive workplace. Ready to apply? If this role matches your experience and goals, we encourage you to apply. Tell us how your experience will help move regulatory strategy forward and support patient access. We look forward to hearing from you.

Italian Salary Range / Fascia retributiva in Italia: EUR 0 to EUR 0 
Belgium Salary Range / Fourchette salariale – Belgique: EUR 90,000 to EUR 150,000 

The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role.

In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process.

This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.


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.

Important notice to Employment businesses/ Agencies

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/