Manager, Global Regulatory Affairs, Oncology

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. 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.

Key Responsibilities:
- Work with GRL, global/regional counterparts, and local operating companies to develop and deliver robust regulatory strategies meeting 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 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 strategic changes.

Basic Qualifications & Skills:
- Bachelor’s degree in biological or healthcare science.
- 1+ years experience in drug development process within regulatory affairs (preferably oncology).
- 1+ years experience with clinical trial requirements in at least one major regional/global market.

Preferred Qualifications & Skills:
- Advanced Scientific Degree (PhD, MD, PharmD).
- Proven ability managing global/regional development, submission, and approval activities.
- Collaborative, proactive problem-solving; innovative solutions within regulatory constraints.
- Digital fluency tools proficiency.
- Strong written and verbal communication skills.
- Experience working effectively in matrix teams.