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Consultant – Regulatory Affairs Officer, Product Registration
Ividata Life Sciences. Prepare, submit, and monitor registration, renewal, and variation applications .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs within the pharmaceutical and healthcare sectors, focusing on registration procedures, compliance with advertising regulations, and effective communication with health authorities. Proficient in managing product documentation and ensuring adherence to medicinal product and food supplement regulations.
Highest-signal resume keywords
Regulatory Affairs ExperienceRegistration Procedures KnowledgeVeeva PromoMats ProficiencyFluent FrenchMedicinal Product Regulations Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Registration ProceduresAdvertising Review ComplianceProduct Documentation DraftingHealth Claims ComplianceRegulatory Deadline Management
Soft Skills
Interpersonal SkillsAutonomyPrioritization SkillsResponsiveness
Tools & Technologies
RIM SystemsVeeva Vault
Certifications & Qualifications
Doctor of PharmacyMaster’s Degree in Regulatory AffairsMaster’s Degree in Health Law
Industry Keywords
Pharmaceutical IndustryHealthcare SectorMedicinal Product RegulationsFood Supplement RegulationsHealth Authorities Communication
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Prepare, submit, and monitor registration, renewal, and variation applications
- Manage the compliance of market launch notifications for medicinal products and food supplements
- Draft and update product documentation, including SmPCs, package leaflets, labeling, and packaging
- Review and approve promotional and advertising materials across print and digital media
- Ensure the compliance of health claims and product communications
- Handle medical information requests from healthcare professionals and patients
- Draft and update standardized responses and FAQs
- Liaise with Quality and Pharmacovigilance teams
- Manage communications with health authorities, including ANSM, DGCCRF, and EFSA
- Meet regulatory deadlines
- Work collaboratively with clients in the pharmaceutical and healthcare sectors on high-value projects
Requirements
What you’ll need- Education: Doctor of Pharmacy or Master’s degree in Regulatory Affairs / Health Law
- At least 2 years of regulatory affairs experience in the pharmaceutical or healthcare industry
- Strong knowledge of registration procedures
- Strong knowledge of advertising review and compliance
- Proficiency in RIM systems and document validation tools, particularly Veeva PromoMats and Veeva Vault
- Knowledge of medicinal product regulations (ANSM/EMA)
- Knowledge of food supplement regulations
- Scientific rigor, responsiveness, strong interpersonal skills, autonomy, and excellent prioritization skills
- Fluent French
- Professional written and spoken English
Benefits
Comp & perks- Stimulating and collaborative environment
- High-impact assignments
- Opportunity to work alongside passionate experts
- Hybrid working arrangements with the possibility of remote work
- Career development in a constantly evolving environment
- Opportunity to contribute to projects for pharmaceutical companies, biotech firms, medical device manufacturers, animal health, cosmetics, and nutrition organizations