Regulatory Compliance Program Jobs (NOW HIRING)

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and product. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Position Summary:

This role leads a team of professionals acting asadvisor,facilitatorand teammemberregardingregulatory compliance andpertinentquality systems for all aspects ofthemanufacturing, testing,storageand distributionof pharmaceutical products.This position will provide guidance and trainingtonew and existing employees andassistthem with decision making.You will lead regulatory compliance activities across US operations. You will work with quality, manufacturing, and technical teams to ensure compliance with regulations and company standards. Your team values clear thinking, practical problem solving, and collaboration. You will have the chance to grow your skills, shape compliance practices, and make a measurable impact on patient safety and public health. Join us to 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. You will lead regulatory compliance programs and ensure alignment with US and global regulatory requirements. Supportinspection readiness including responses to regulatory authority requests and audits. Manage regulatory risk assessments and drive corrective and preventive actions to closure. Collaborate with cross-functional teams to implement compliance plans and improve processes. Prepare clear reports and metrics for leadership on compliance status and improvement initiatives. Coach and influence colleagues to build a proactive compliance culture across the organization.

• Ensuringall proposed technical changesareproperly assessedviatheChange Control System, providing guidance to the impact on regulatory submissions,RIS (Regulatory Implementation Strategy)and using this information to assistchange owners in the assessment of scope for the change.

Basic Qualifications:

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

• 8+years' experiencein cGMP environment, with5+ years in regulatory affairs or a quality or regulatory compliance rolewith hands-on regulatory compliance experience in a regulated industry (pharmaceutical, biotech, or similar). Must have a minimum2yearsas a people leader.

• BS or BA in relevant technical discipline, including life sciences, engineering, regulatory affairs, or a related field, or equivalent experience.Sufficient technical depth or professional experience will be considered in lieu of technical degree.

• Demonstrated experience with GMP's, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical and stabilityfunctionsand compliance.

Preferred Qualifications:

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

• Advanced degree in a relevant scientific or technical discipline.

• Good written communication, organizational, and computer skills. le to prioritize and decideappropriate courseofactions.Effective at implementingdecisions.

• Able to interact with peers,subordinateand senior personnel inmultidisciplinaryenvironmentincluding engineering, facility operations, validation,productionand QC.

• Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).

• Good understanding and interpretation of Global regulationspertaining tothe manufacture, holding, and distribution of human drug products.

• Good working knowledge of regulatory affairs, including submissions/supplements/variations and approved dossiers.

• Demonstrated experience supporting regulatory inspections and audit activities. Strong knowledge of US regulatory requirements and good manufacturing practices.

• Proven ability to lead cross-functional projects and influence stakeholders.

• Excellent written and verbal communication skills with attention to detail.

• Experience with global regulatory interactions and harmonization activities.

• Experience coaching teams and building compliance capability.

• Familiarity with quality management systems and trending tools.

• Experience writing regulatory submissions or formal responses to authorities.

• Prior experience in continuous improvement or operational excellence programs.

Work Arrangement:

This role is hybrid. You will be expected to work on-site regularly, with flexibility for remote work as agreed with your manager.

What you can expect from us:

You will join a team that values inclusion, clear communication, and practical action. We support learning and career development. We welcome different perspectives and want people who will help us do the right thing for patients, safely and reliably.
Ready to apply?

If this role fits your experience and ambitions, we encourage you to apply. Share a concise summary of how your background matches the basic qualifications and a short example of a compliance challenge you led. We look forward to hearing from you.

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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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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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