Manager, Global Regulatory Affairs, Oncology

Global Regulatory Affairs Manager (Oncology)

Key Responsibilities:
- Develop and deliver global and regional 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 change.

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

Preferred Qualifications & Skills:
- Advanced Scientific Degree (PhD, MD, PharmD).
- Experience managing global and regional development, submission, and approval activities.
- Ability to foster collaboration, proactively resolve challenges, and develop innovative solutions within regulatory constraints.
- Proficiency in digital fluency tools.
- Strong written and verbal communication skills.
- Experience working effectively in matrix teams.

Benefits (US, if applicable):
- Annual bonus; eligibility for share-based long-term incentive; health care and other insurance, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Application instructions:
- If you require an accommodation or other assistance to apply, email us at usrecruitment.adjustments@gsk.com.