Manager, Global Regulatory Affairs (Oncology)
$138750/y-$231250/y
GSK3 days ago
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OnsiteFull-timeEntry
Summary
GSK is seeking a Manager, Global Regulatory Affairs (Oncology) to join their team in Collegeville, PA. The role involves developing and executing global and regional regulatory strategies for oncology assets.
About the Role
As a Global Regulatory Affairs Manager, you will be responsible for developing regulatory strategies to ensure timely submission and approval of clinical trial applications. You will collaborate with cross-functional teams and maintain compliance with regulatory requirements throughout the product lifecycle. Your role will also involve assessing regulatory intelligence to refine strategies.
About You
Required:
- Minimum of a Bachelor’s degree in biological or healthcare science.
- Minimum of 1 year experience in the drug development process within regulatory affairs.
- Proven ability to manage development, submission, and approval activities in different regions globally.
- Minimum of one year of experience in clinical trial requirements in at least one region (EU or US).
Preferred:
- Advanced Scientific Degree (PhD, MD, PharmD).
- Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs.
- Strong matrix working skills.
- Proactive problem-solving skills.
- Creative regulatory problem-solving capabilities.
- Focus on continuous improvement and excellence.
- Ability to develop networks within GSK.
Benefits
- Annual base salary range of $138k–$231k.
- Annual bonus eligibility.
- Participation in share-based long-term incentive program.
- Health care and other insurance benefits for employee and family.
- Retirement benefits.
- Paid holidays and vacation.
- Paid caregiver/parental and medical leave.
GSK
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Collegeville, PA