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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs within the biopharmaceutical industry, with a strong understanding of global codes and standards, including EFPIA and IFPMA. Capable of interpreting complex clinical data and supporting digital transformation initiatives while maintaining high-quality standards.
Highest-signal resume keywords
Regulatory Affairs ExperienceUnderstanding Of EFPIA And IFPMA StandardsExperience With Veeva And Microsoft OfficeAbility To Interpret Clinical DataStrong Attention To Detail
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 Advertising And Promotion ReviewClinical Trial DesignData AnalysisQuality Standards DefinitionKPI ReportingSOP RevisionsDigital Transformation InitiativesMedical Publication InterpretationPromotional Regulatory RequirementsGap Analysis
Soft Skills
Clear CommunicationOrganizational SkillsCollaborationAdaptabilityProactivity
Tools & Technologies
VeevaMicrosoft OfficeSharePointDigital ToolsRegulatory Technology Systems
Industry Keywords
Biopharmaceutical IndustryPharmaceutical Regulatory ConceptsGlobal Promotional ActivitiesClinical Data InterpretationDisease Awareness Content
About the role
Key responsibilities & impact- Support global promotional and non-promotional material regulatory review and prior approval
- Advise teams on global and local affiliate promotional activities
- Review regulatory aspects of global internet websites and social media
- Define worldwide minimum quality standards and processes
- Support guidelines and quality documents related to promotional regulatory requirements
- Advise on evolving regulatory requirements, industry trends, enforcement actions, and pharmaceutical advertising complaints
- Represent GRA Ad-Promo in transformation programs and cross-functional initiatives
- Support evaluation and testing of digital tools and Gen AI use cases
- Compile data and observations for system and process reviews
- Coordinate with transversal partners and regional teams
- Prepare materials and communications for stakeholder meetings and updates
- Support gap analyses, KPI reporting, dashboards, best-practice documentation, process updates, and SOP revisions
- Maintain global training materials and conduct upskilling sessions with regional regulatory teams
- Provide administrative and coordination support for governance activities, town halls, and workshops
Requirements
What you’ll need- BA/BS degree in Pharmaceutical Sciences, Life Sciences, or a related discipline, or 2+ years of direct experience for candidates with degrees outside these fields
- 2+ years of experience in the biopharmaceutical industry supporting regulatory affairs, regulatory advertising and promotion review, or similar functional areas
- Good understanding of global codes and standards, including EFPIA and IFPMA standards
- Ability to interpret complex clinical data, including CSRs and medical publications
- Scientific and clinical knowledge of disease states, mechanisms of action, clinical trial design, and statistical concepts
- Ability to use data and local SmPC to inform compliant messaging
- Understanding of review standards for branded, disease awareness, and medical congress content
- Experience supporting transversal and/or digital transformation initiatives such as Gen AI, Modular Content, Core Claims, or other MLR programs
- Familiarity with regulatory technology systems such as Veeva and digital tools such as Microsoft Office and SharePoint
- English fluent required; additional languages beneficial
- Strong attention to detail and commitment to quality
- Foundational understanding of pharmaceutical regulatory concepts, or willingness to develop this quickly
- Good organizational and coordination skills
- Clear and professional written and verbal communication
- Collaborative, adaptable, and proactive approach
Benefits
Comp & perks- Supportive, future-focused team
- Opportunities for promotion or lateral career moves, at home or internationally
- Thoughtful rewards package
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs
- Access to cutting-edge AI, data, and digital platforms
- Opportunities to collaborate with diverse teams across science, clinical, and digital fields