Director, Global Regulatory Affairs
$166650/y-$277750/y
2 days ago
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OnsiteFull-timeDirector
Summary
GSK is seeking a Director, Global Regulatory Affairs to join their team in Collegeville, PA. The role involves leading the development and execution of regulatory strategies for assigned assets to ensure the availability of safe and effective treatments worldwide.
About the Role
As the Director of Global Regulatory Affairs, you will be accountable for developing regional and global regulatory strategies aligned with the Medicines Development Strategy. You will work closely with local and regional commercial teams, lead regulatory interactions, and ensure compliance with regional requirements throughout the product life cycle.
About You
Required:
- Bachelor’s degree in Biological or Healthcare Science.
- 10+ years of experience in regulatory affairs across all phases of drug development.
- Proven track record in leading regional development, submission, and approval activities.
- Experience working on clinical trial and licensing requirements in major countries.
Preferred:
- PhD in Biological or Healthcare Science.
- Experience with projects involving little or no precedence in regulatory affairs.
- Expertise in developing product or therapeutic knowledge in new areas.
- Familiarity with digitalization in regulatory strategy to enhance decision-making and innovation.
- Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance.
- Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.
Benefits
- Annual base salary ranging from $166k to $278k.
- Annual bonus and eligibility to participate 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