Manager, Global Regulatory Affairs, Oncology

GSK•Waltham, PA

4d•Onsite

About The Position

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. As a Global Regulatory Affairs Manager at GSK, you will develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions. We value clear thinking, collaboration, practical problem solving and a patient-first mindset.

Requirements

Bachelor’s degree in biological or healthcare science.
1+ years experience in the drug development process within regulatory affairs, preferably oncology.
1+ years of experience in clinical trial requirements in at least one major regional/global market.

Nice To Haves

Advanced Scientific Degree (PhD, MD, PharmD).
Proven ability in managing global and regional development, submission, and approval activities.
Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints.
Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation.
Strong written and verbal communication skills for clarity and impact.
Experience working effectively in matrix teams.

Responsibilities

Work closely with GRL, global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements.
Collaborate with cross-functional teams to align regulatory plans with Medicines Development Strategy and Integrated Asset Plan.
Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval.
Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision-making.
Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle.
Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes.