
Regulatory Affairs Associate
Reckitt
full-time
Posted on:
Location Type: Office
Location: Massy • France
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About the role
- Ensure regulatory compliance of assigned product ranges, including adherence to applicable regulations, quality standards, advertising rules, and market authorization requirements
- Maintain and update product dossiers, regulatory databases, and Marketing Authorizations (MA), including coordinating national/EU submissions, variations, renewals, and delistings
- Support new product development (NPD/EPD) by providing regulatory guidance on product status, claims, labeling, packaging, and technical documentation
- Contribute to the development, revision, training, and implementation of regulatory Standard Operating Procedures (SOPs)
- Participate in regulatory audits/inspections, support preparation activities, and follow up on corrective and preventive actions (CAPAs)
- Validate packaging and promotional materials for medicines and health products, ensuring compliance with legal requirements (ANSM, ARPP, AMM, GPC)
- Manage operational regulatory tasks, including batch release documentation checks, stock break declarations, recalls, vigilance reporting, and exchange controls
- Provide medical/pharmaceutical information by responding to inquiries from healthcare professionals and patients and maintaining traceability/FAQ databases
- Ensure vigilance monitoring within scope and act as Deputy DSO when required
- Support transparency, ethics, and medical‑economic activities (e.g., transparency disclosures, pricing/transparency files for CEPS/HAS)
Requirements
- Minimum 3 years of experience in Regulatory Affairs and/or Vigilance within the pharmaceutical industry
- Strong understanding of regulatory frameworks, product compliance, and quality systems
- Excellent organizational skills, including multitasking, prioritization, and meeting deadlines
- Strong attention to detail, rigor, and ability to work autonomously
- Effective interpersonal skills with a strong team-oriented mindset
- High adaptability in a fast‑paced and evolving regulatory environment
- Proactive approach with the ability to anticipate needs and propose solutions
- Demonstrated initiative and willingness to challenge the status quo to improve processes
- Fluent English & French (written and spoken)
- Strong proficiency with Microsoft Office Suite (Pack Office)
- Solid scientific knowledge in pharmaceuticals
- Sound understanding of regulatory affairs practices and requirements
- Knowledge of medical–economic concepts (e.g., pricing, reimbursement, health economics)
Benefits
- Parental benefits
- Employee Assistance Program to promote mental health
- Life insurance for all employees globally
- Opportunity to save and share in Reckitt's potential future successes
- Short-term incentives to recognize, appreciate and reward your work
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory complianceproduct compliancequality systemsregulatory frameworksregulatory Standard Operating Procedures (SOPs)vigilance monitoringmedical informationpackaging validationtechnical documentationmedical–economic concepts
Soft Skills
organizational skillsmultitaskingattention to detailinterpersonal skillsteam-oriented mindsetadaptabilityproactive approachinitiativeproblem-solvingautonomy