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Manager, Global Regulatory Affairs, Oncology

GSK
15 days ago
Remote friendly (Durham, NC)
United States
Corporate Functions
Key Responsibilities:
- Work closely with Global Regulatory Lead (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 strategic change implementation.

Basic Qualifications & Skills (Required):
- 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.

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

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

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