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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 global and regional projects, ensuring compliance with regulatory requirements and GSK processes. Possesses strong clinical regulatory experience and knowledge of drug development phases, with the ability to influence stakeholders effectively.
Highest-signal resume keywords
Regulatory Affairs ExperienceClinical Regulatory ExperienceKnowledge Of Drug Development ProcessExperience In Regulatory InteractionsProficiency In Digital Tools And AI
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 Strategy DevelopmentRegulatory Submissions ManagementRegulatory Review ProcessesClinical Trial Requirements KnowledgeLicensing Requirements Knowledge
Soft Skills
Problem-Solving ApproachStrong People SkillsAbility To Influence
Tools & Technologies
Digital ToolsAI
Industry Keywords
EU Regulatory AffairsUS Regulatory AffairsImmunologyInflammationTherapeutic Groups
About the role
Key responsibilities & impact- Develop appropriate global and regional regulatory strategies for assigned assets
- Execute regulatory strategies to support global projects
- Manage regulatory interactions and review processes in local regions
- Interact with global/regional counterparts and commercial teams
- Ensure compliance with GSK processes, policies, and regulatory requirements
- Assess regulatory precedent, intelligence, and the competitive environment
- Evaluate impacts on regulatory strategy for assigned assets
- Develop and deliver regulatory subject matter expertise across GSK
- Report directly to a Director (Team Lead) for Therapeutic Groups (RII)
Requirements
What you’ll need- Degree-educated in relevant scientific or technical discipline (or very strong relevant experience)
- Relevant regulatory affairs experience in the EU and/or US and other major markets
- Experience developing and implementing regional strategies, managing regulatory interactions, submissions, and review processes
- Clinical regulatory experience is a must
- Knowledge of all phases of the drug development process
- Ability to develop necessary specialist knowledge for the product or area of medicine
- Proficiency in digital tools and AI
- Knowledge of clinical trial and licensing requirements in all major countries in the region
- Strong experience working in complex technical situations
- Demonstrable clear problem-solving approach
- Strong people skills and proven ability to influence people to achieve and drive performance
- Experience in all phases of the drug development process in regulatory affairs (preferred)
- Experience in relevant therapy area, especially Immunology & Inflammation (preferred)
Benefits
Comp & perks- Annual bonus may be offered
- Eligibility to participate in a 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
- Agile working culture and flexibility opportunities
- Adjustments to the recruitment process upon request