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Regulatory Affairs Senior Project Manager M/F Permanent Position

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Job Description:

Your missions: ‐ Preparation of files IND/CTA and Regulatory files (AMM…). You contribute to the preparation of these files: accepting the request for approval and their coherence with strategy and objectives; you ensure the interface with Authorities during evaluation and work with the local RA managers and local regulatory representatives; you support these partners in the preparation and registration files for all markets. ‐ Regulatory support for projects in development: Representing RA within project teams and steering committees, you contribute to the regulatory strategy’s development and consult authorities for ongoing projects and coordination of these consultations, you perform analysis of the regulatory and competitive environment, and bring your expertise in the interpretation of regulatory requirements and analysis issues. ‐ Representing Regulatory Affairs in regulatory and scientific consultation meetings with health authorities.

Profil / Qualifications Requises

PharD, MD, you have minimum 5‐10 years’ experience in Regulatory Affairs or in Development in an international context including active participation in consultation meetings with scientific and regulatory health authorities. You have good knowledge in non‐clinical, clinical and pharmaceutical domains. Excellent analytical skills, excellent communication skills, good international relationship are required. English fluent. Position located in South of France. The next step is yours. If you want to join an international leading company and apply for this challenging vacancy, upload your cover letter and resume/CV (ref AR2207) to: http://www.acavi.fr/anglais/nos‐offres‐d‐emploi.php?id=4‐o=3




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