- Salary
- $222k – $370k
- Location
- Upper Providence, United States of America · Waltham · Durham Blackwell Street
- Workplace
- Remote
- Type
- Full-time
- Department
- Legal
- Seniority
- Senior
- Experience
- 10+ years
- Education
- PhD
- Closing date
- Today
- Source
- Workday
Description
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
Key Responsibilities
- Lead or oversee the development and execution of regulatory strategies for assigned assets, ensuring alignment with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements.
- Provide regulatory leadership for assigned programs, including assessment of regulatory precedent, regulatory intelligence, competitive landscape, and potential impact on asset strategy.
- Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes, as applicable to assigned programs.
- Work with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and other cross-functional stakeholders to support regulatory strategy and labeling objectives that are consistent with available data.
- Serve as a point of accountability for assigned regulatory work packages and lead or contribute to Regulatory Matrix Team activities, as applicable.
- Ensure regulatory activities are conducted in accordance with applicable laws, regulations, internal policies, and GSK expectations.
- Provide regulatory input into due diligence, business development, or portfolio-level assessments, as needed.
- Where the role includes people leadership, manage and develop direct or indirect team members, support workforce planning, contribute to resource management, and help build effective, inclusive teams.
- Partner with senior stakeholders to support portfolio-level strategy, resource planning, operating model development, and delivery of longer-term objectives or large-scale initiatives.
- Communicate regulatory strategy, risks, options, and recommendations clearly to senior leaders, health authorities, and cross-functional partners.
Why You?
Work arrangement: Hybrid, with regular presence at a US site for leadership activities and key meetings. Remote-first candidates may be considered if located in the United States and able to travel as required.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in Biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
- 10+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry. (The source calls for extensive regulatory experience across all phases of development; 10+ years aligns with typical US Senior Director market practice.)
- 7+ years of experience supporting drug development programs spanning multiple phases of clinical development.
- 5+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology
- Experience leading or serving as the regulatory lead for at least one major regulatory submission, approval, or significant lifecycle management submission with a Health Authority.
- Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings.
- Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions.
- Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs.
- Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions.
- Experience influencing senior stakeholders and providing strategic regulatory recommendations in a matrix environment.
- Demonstrated experience ensuring compliance with applicable regulatory requirements, industry standards, and company policies throughout the product lifecycle.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Advanced degree (MS, PharmD, PhD, MD, or equivalent) in a scientific discipline.
- 12+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
- Experience supporting business development, licensing, acquisitions, or due diligence activities.
- Experience leading regulatory activities across multiple geographic regions.
- Experience managing regulatory professionals in a global matrix environment.
- Experience incorporating digital, AI-enabled, or data-driven approaches into regulatory strategy or decision-making.
How to apply
If this role matches your experience and goals, please apply with your CV and a short note about what motivates you to join and contribute to our mission. We encourage applicants from all backgrounds and welcome conversations about reasonable accommodations during the application process. We look forward to hearing from you.
Skills
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management
• 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 $222,000 to $370,000. 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 - [email protected]
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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