The posting
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
We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organization, supporting our Oncology portfolio. As Director, Global Regulatory Strategy, you will provide strategic regulatory leadership for assigned oncology assets, working across global and regional teams to shape development programs and deliver innovative, effective regulatory strategies. You will operate as a senior individual contributor, bringing deep regulatory insight, strong scientific understanding and sound judgement to complex oncology development decisions. Depending on portfolio needs, you may serve as Global Regulatory Lead or Team Lead for selected assets, leading regulatory strategy and engagement with health authorities throughout development, registration and the product lifecycle.
What you’ll do
- Develop and execute innovative, evidence-based global and regional regulatory strategies for assigned oncology assets and development programs.
- Ensure regulatory strategy is integrated with medicines development plans, clinical development and evidence-generation strategies, and the requirements of priority markets.
- Provide strategic regulatory leadership to cross-functional oncology development teams and act as a key point of accountability for assigned assets.
- Assess regulatory precedent, intelligence and the competitive oncology landscape to identify opportunities, risks and implications for development strategy.
- Translate complex scientific, clinical and regulatory information into clear recommendations that enable timely, well-informed development decisions.
- Develop regulatory strategies that consider the unique complexities of oncology drug development, including accelerated or expedited development pathways, novel clinical-development approaches, biomarker-driven strategies and companion diagnostics, where applicable.
- Lead regulatory matrix teams and coordinate delivery of regulatory activities across functions and geographies.
- Lead health-authority interactions, regulatory submissions, milestone meetings and review processes.
- Partner effectively with clinical development, safety, medical, commercial, biomarker, diagnostics and local regulatory colleagues.
- Develop regulatory approaches that support appropriate labelling based on the available clinical evidence and applicable regulatory requirements.
- Anticipate regulatory risks and emerging issues and develop practical strategies to address them.
- Ensure compliance with applicable regulatory requirements throughout development and the product lifecycle.
- Represent regulatory perspectives with senior leaders and health authorities, advocating clearly and credibly for evidence-based regulatory approaches.
- Contribute regulatory expertise to due-diligence, licensing and business-development activities where required.
- Identify opportunities to use digital capabilities, regulatory intelligence and new approaches to strengthen decision-making and improve efficiency.
Basic qualifications and experience
We are looking for candidates with:
- A bachelor’s degree or equivalent relevant professional experience in biological science, healthcare science or a related discipline.
- Significant regulatory-affairs experience (5+ years) across pharmaceutical development and the product lifecycle.
- Experience developing and delivering regulatory strategies for oncology development programs.
- Experience leading regulatory submission and approval activities.
- A track record of leading interactions or milestone meetings with health authorities.
- Experience providing regulatory leadership within global, cross-functional matrix teams.
- Strong knowledge of clinical-trial and marketing-authorisation requirements in major markets, together with a sound understanding of the global regulatory environment.
- Strong understanding of oncology drug development and the scientific and clinical considerations that influence regulatory strategy.
Preferred qualifications and experience
The following would be advantageous:
- A master’s degree, PhD or other advanced scientific or regulatory qualification.
- Broad regulatory experience supporting oncology medicines across development, registration and lifecycle management.
- Experience acting as a Global Regulatory Lead, Regional Regulatory Director or in a comparable strategic regulatory role.
- Experience leading oncology regulatory activities across multiple geographic regions, particularly the US and EU.
- Experience working across different stages of oncology development, from early development through registration and lifecycle management.
- Experience with expedited regulatory pathways and approaches commonly used in oncology development, such as breakthrough or accelerated development strategies.
- Experience supporting biomarker-driven development, precision medicine strategies or companion diagnostics.
- Experience leading regulatory strategy where there is limited precedent, significant scientific complexity or a rapidly evolving treatment landscape.
- Experience interpreting regulatory precedent and the external competitive environment to inform oncology development strategy.
- Strong influencing and communication skills, including the ability to make complex scientific and regulatory issues clear to different audiences.
- Demonstrated ability to build effective relationships and influence decisions without formal authority.
- A strong commitment to quality, ethical conduct and compliance with applicable laws, regulations and company requirements.
- Strong clinical and scientific understanding of oncology drug development.
- Experience applying regulatory intelligence, data or digital approaches to development and regulatory decision-making.
Work Arrangement This role is hybrid, based in the United States or United Kinddom. You will be expected to attend regular meetings and leadership activities at a GSK site, 2-3 days per week minimum.
Are you ready to grow your regulatory career with a team dedicated to improving health worldwide? Apply now to join GSK and help us get ahead of disease together.
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 $171,750 to $286,250. 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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