Senior Manager - CMC RA 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 global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for biopharmaceutical development projects. You will work in cross-functional teams to prepare regulatory submissions, advise on manufacturing and quality risks, and support interactions with regulators. We value clear thinkers who build trusting relationships, move work forward with purpose, and help their teams grow. This role offers stretch, visible impact and the chance to help GSK unite science, technology and talent to get ahead of disease together.

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

• - Lead development and implementation of global CMC regulatory strategies from early development through early lifecycle activities.
• - Author, review and deliver CMC content for regulatory submissions and responses that meet global requirements.
• - Identify CMC regulatory risks and present clear, practical mitigation plans to project teams and senior leaders.
• - Collaborate across regulatory, quality, manufacturing, development and external partners to enable timely submissions and supply continuity.
• - Represent CMC in regulatory interactions and prepare teams for agency meetings and inspections.
• - Coach and mentor colleagues, share best practice and contribute to process improvements.

• Responsibilities
• You will work on biologics and complex development projects and be accountable for CMC regulatory deliverables. Your work will help projects progress safely and on schedule. You will influence decisions and ensure submissions are clear, accurate and aligned with business needs. You will support change that improves speed and quality while protecting product supply for patients.

• 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 experience in biologics or biopharmaceutical development.
• - Experience preparing and/or authoring CMC sections for regulatory submissions for the US and global authorities.
• - Practical knowledge of manufacturing, analytical methods, stability, and quality systems relevant to biologics.
• - Experience working in cross-functional teams and managing multiple projects or deliverables.
• -

• Preferred Qualification
• If you have the following characteristics, it would be a plus
• - Advanced degree (Master’s or PhD) in a relevant scientific discipline.
• - Direct experience interacting with US regulators (e.g., FDA) or leading agency meetings.
• - Experience with eCTD Module 3 and lifecycle maintenance submissions.
• - Track record mentoring staff and leading small project teams.
• - Experience supporting inspections or regulatory quality incidents.
• - Familiarity with global guidelines (ICH) and biopharmaceutical-specific regulatory expectations.

-Strong written and verbal communication skills in English, with experience presenting technical content to non-technical audiences.

• Working model
• This role is based in the United States and follows a hybrid working model. Expect to be on-site on average 2 to 3 days per week, with flexibility to balance focused remote work and in-person collaboration.

• Ready to apply?
• If you are motivated to shape CMC regulatory strategy and help bring important biopharmaceuticals forward, we encourage you to apply. Tell us how your experience matches the role and what impact you want to make at GSK. We look forward to hearing from you.

Skills

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership

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 $144,375 to $240,625. 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.Italian Salary Range / Fascia retributiva in Italia: EUR 57,300 to EUR 95,500Belgium Salary Range / Fourchette salariale – Belgique: EUR 90,000 to EUR 150,000The 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 fo