STAGE Affaires Réglementaires Pharmaceuticals (H/F/NB)
Core
Intern role supporting the Regulatory Affairs team in ensuring the development, registration, and availability of pharmaceutical products for patients in compliance with regulatory requirements.
Role type
Intern, Regulatory Affairs (Pharmaceuticals)
Builds
Regulatory dossiers and documentation for pharmaceutical products
Domain
Pharmaceuticals, Regulatory Affairs (via careerplan.io/jobs/562949978421630-stage-affaires-reglementaires-pharmaceuticals-hfnb-at-bayer)
Required skills
Pharmaceutical studies (5th year), regulatory procedure knowledge, dossier preparation, risk minimization documentation, regulatory monitoring, Office software proficiency
Preferred skills
English language skills, digital tool adaptability
Responsibilities
Discover European and national registration procedures; Participate in the preparation and maintenance of AMM dossiers and drug variations; Participate in regulatory control of leaflets, labels, and packaging; Participate in regulatory control of promotional materials; Contribute to risk minimization document activities; Perform regulatory monitoring and analyze the impact of regulatory changes; Participate in updating procedures, training materials, and internal documents; Discover interactions with French and European health authorities.