Director, Global Regulatory Affairs
GSK
full-time
Posted on:
Location Type: Office
Location: Waltham • California, Maryland, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $166,650 - $277,750 per year
Job Level
Lead
About the role
- Lead the development of regional / global regulatory strategies and their execution for assigned asset(s)
- Ensure the regulatory strategy will deliver the needs of the local region(s)
- Implement the regional strategy(s) in support of the project globally
- Lead regulatory interactions and the review processes in local region
- Ensure appropriate interaction with regional commercial teams in local region
- Ensure compliance with regional requirements at all stages of product life
- Advocate persuasive approaches to senior leaders in GSK and in Health Authorities
- Capable of providing assessment of potential in license molecules
Requirements
- 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
- PhD in Biological or Healthcare Science (preferred)
- Experience with projects involving little or no precedence in regulatory affairs (preferred)
- Expertise in developing product or therapeutic knowledge in new areas (preferred)
- Familiarity with digitalization in regulatory strategy to enhance decision-making and innovation (preferred)
- Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance (preferred)
- Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders (preferred)
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyregulatory affairsdrug developmentclinical trial requirementslicensing requirementsproduct knowledgetherapeutic knowledgedigitalization in regulatory strategycompliancecreative solutions
Soft skills
communication skillsleadership skillsnetwork buildingstakeholder influencepersuasionproblem-solving
Certifications
Bachelor’s degree in Biological ScienceBachelor’s degree in Healthcare SciencePhD in Biological SciencePhD in Healthcare Science