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Director, Regulatory Affairs – Precision Medicine, Digital Health
GSK. Develop appropriate Precision Medicine and Digital Health regulatory strategies and execute them for assigned assets across GSK’s therapeutic portfolio .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and executing regulatory strategies for Precision Medicine and Digital Health, ensuring compliance with global and regional requirements while leading cross-functional teams and stakeholder interactions.
Highest-signal resume keywords
Regulatory Strategy DevelopmentGlobal Development and Submission ActivitiesPrecision Medicine and Digital Health ComplianceClinical Trial and Licensing RequirementsMilestone Meeting Execution
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ConsiderationCompanion DiagnosticsSoftware as a Medical Device (SaMD)FDA Submission and ApprovalProduct Life Cycle ComplianceMatrix WorkingRegulatory Interaction LeadershipCreative Regulatory Problem SolvingDecision Making with Incomplete Information
Soft Skills
Excellent Communication SkillsConflict ResolutionGroup FacilitationRelationship BuildingChange Leadership
Certifications & Qualifications
Bachelor's Degree in Biological ScienceBachelor's Degree in Healthcare SciencePhD in Biological Science (Preferred)PhD in Healthcare Science (Preferred)
Industry Keywords
Precision MedicineDigital HealthHealth Authority InteractionRegulatory ComplianceClinical Trial RequirementsLicensing RequirementsGlobal Regulatory StrategyMatrix CollaborationMilestone Meetings
About the role
Key responsibilities & impact- Develop appropriate Precision Medicine and Digital Health regulatory strategies and execute them for assigned assets across GSK’s therapeutic portfolio
- Support global and regional regulatory approaches and ensure compliance with GSK processes, policies, and regional regulatory requirements
- Plan over a multiple-year horizon and deliver through extensive matrix working within GSK up to VP level
- Work closely with Precision Medicine and Digital Health teams
- Collaborate with regional regulatory affiliates to create a regional collaboration framework for Precision Medicine and Digital Technologies
- Lead regulatory interactions and review processes for GSK
- Ensure compliance with regulatory requirements throughout the product life cycle from C2MD
- Advocate approaches to senior GSK leaders and Health Authorities
- Assess Precision Medicine and Digital Health components for potential in-license molecules
- Organize and execute milestone meetings
Requirements
What you’ll need- Bachelor’s degree in biological or healthcare science
- 5+ years experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD, including for projects with little or no precedence
- Experience of leading global development, submission and approval activities (FDA)
- Capable of organizing and executing successful milestone meetings
- Track record of successful relationship with one or more Health Authority
- Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in major countries
- Candidates open to remote work within the U.S. may be considered if they can travel as needed
- PhD in a biological or healthcare science (preferred)
- Excellent communication skills (preferred)
- Proven ability to foster strong matrix working (preferred)
- Proven ability to facilitate groups and create solutions (preferred)
- Ability to lead change and communicate difficult messages (preferred)
- Proven ability to build strong personal networks and develop an external network (preferred)
- Proven ability to recognize and resolve conflict (preferred)
- Proven ability to derive creative solutions to regulatory problems while ensuring compliance (preferred)
- Proven ability to make sound decisions with incomplete information (preferred)
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in 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
- Accommodation or other assistance to apply for a job