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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 maintaining global regulatory strategies, managing submissions, and leading interactions with Health Authorities. Proficient in regulatory risk assessment and lifecycle management within the pharmaceutical or biotechnology industry.
Highest-signal resume keywords
Global Regulatory StrategyRegulatory Affairs ExpertiseCross-Functional Team LeadershipRegulatory Submissions ManagementStakeholder Influence
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 DevelopmentLifecycle ManagementRegulatory SubmissionsRegulatory Risk AssessmentCTA/IND DocumentationCTD Modules PreparationLabel DevelopmentRegulatory Due DiligenceMarket Expansion StrategiesRegulatory Intelligence Assessment
Soft Skills
Influencing StakeholdersDriving Strategic DecisionsCollaboration
Certifications & Qualifications
Master's DegreePharmDPhDMD
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryHealth AuthoritiesEMAFDAICHOrphan Drug DesignationMarket AccessRegulatory FrameworksGlobal Submission Plans
About the role
Key responsibilities & impact- Develop and maintain global regulatory strategies aligned with development and business objectives
- Assess evolving regulatory requirements, competitor landscapes, and regulatory intelligence across major markets
- Lead interactions with Health Authorities, including EMA, FDA, PMDA, and other key agencies
- Drive regulatory activities related to registrations, lifecycle management, orphan drug designation, and market expansions
- Design and oversee global submission plans with regional regulatory teams and submission management
- Act as a core member of global cross-functional project teams
- Ensure alignment across Regulatory Affairs, Clinical Development, Safety, CMC, Market Access, and other stakeholders
- Support preparation and maintenance of CTA/IND documentation, CTD modules, briefing books, regulatory Q&A packages, PIP/PSP activities, and other regulatory deliverables
- Lead label development activities and contribute to Company Core Data Sheets (CCDS)
- Manage regulatory risk assessments and maintain regulatory risk registers
- Support registration activities in key markets and contribute to regulatory due diligence and licensing initiatives when required
- Evaluate regulatory impacts of quality, efficacy, or safety findings throughout product development
Requirements
What you’ll need- Master's Degree, PharmD, PhD, MD, or equivalent scientific qualification
- Advanced experience in Regulatory Affairs
- Proven expertise in global regulatory strategy, registrations, and lifecycle management within the pharmaceutical or biotechnology industry
- Strong knowledge of global regulatory frameworks, including ICH, EMA, and FDA
- Experience supporting product development, submissions, and regulatory interactions with Health Authorities
- Demonstrated ability to lead cross-functional teams
- Ability to influence stakeholders and drive strategic decisions in a complex international environment
- Fluent in English
Benefits
Comp & perks- Opportunity to contribute to the development of scientific, operational, and human knowledge
- Diverse and stimulating projects through a one-stop provider service model
- Collaboration with leading experts
- Inclusive environment valuing natural talents and individual growth
- Opportunities to grow through full-service, functional service provider, and consulting projects
- Teamwork-focused healthcare company culture
- Employee experience focus
- Environment encouraging boldness, boundary-pushing, and development of potential