Vice President, Global Regulatory Affairs Strategy
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts • Pennsylvania • United States
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Salary
💰 $315,750 - $526,250 per year
Job Level
About the role
- Oversee regulatory strategy globally for the RI&I portfolio
- Act as a direct link between Regulatory Affairs and all RI&I R&D stakeholders
- Ensure appropriate regulatory compliance in the conduct of global development programs
- Drive sound regulatory practices integrated into pre-clinical, clinical, and technical submissions
- Contribute to the creation and implementation of development plans to maximize successful regulatory applications
- Develop and maintain relationships with FDA, EMA, PMDA, CFDA, and other key international regulatory agencies
- Provide leadership to assure appropriate regulatory compliance in clinical trials
Requirements
- Bachelors degree in Pharmacology, Immunology, Biology
- Experience leading the development of regulatory strategy within development programs
- Experience working in early phase and late phase development projects as well as life-cycle
- People management and project leadership skills
- Regulatory affairs/product development experience of which a significant part has been in a senior role
- Experience of collaboration with the FDA/EMEA/significant agencies and evidence of success in gaining product approvals and defending established products.
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
regulatory strategyregulatory complianceclinical trialsdevelopment plansregulatory applicationsproduct approvalslife-cycle managementearly phase developmentlate phase developmentproject leadership
Soft Skills
people managementleadershipcollaboration