Regulatory Affairs
il y a 1 semaine
Depuis 1993, ProductLife Group (PLG) accompagne ses clients tout au long du cycle de vie des produits des sciences de la vie, combinant expertise locale et portée mondiale et couvrant plus de 140 pays.
PLG est une société de conseil en sciences de la vie qui propose des services externalisés dans les domaines des affaires réglementaires, de la qualité et de la conformité, de la vigilance et de l'information médicale.
Notre expertise s'étend à la fois à la surveillance des produits établis et aux thérapies et diagnostics innovants.
Pourquoi rejoindre PLG ?
- Société Internationale
- Multi-Projets sur divers types d'activité et produits en pharma, cosmétique, biotech et médical
- Projets de grande envergure/auprès de clients à renommée internationale
- Montée en compétences
- Une équipe dynamique et motivée
Vous aurez pour missions de :
- Participer à l'élaboration de la stratégie réglementaire CMC (stratégie de validation, choix des spécifications, stability plan)
- Accompagner la réalisation de la feuille de route réglementaire CMC, en interaction directe avec les clients
- Préparer, rédiger et compiler des documents réglementaires CMC (Module 3 complet, Quality Overall Summary, IMPD, dossiers de variations) pour des petites molécules et/ou des molécules larges (produits biologiques)
- Examiner et évaluer la conformité des documents CMC (Module 3 complet, Quality Overall Summary, IMPD, dossiers de variations) en fonction de l'état de l'art, des lignes directrices actuelles, des exigences locales et des directives des clients en effectuant une analyse des lacunes des documents réglementaires
- Agir comme point de contact au nom des clients pour les consultations réglementaires CMC avec les agences réglementaires (ANSM, EMA, FDA.)
- Participer à la préparation des réponses aux questions des agences
- Conseiller le développement pharmaceutique : analyse des rapports de validation ou de stabilité
- Assurer la conformité réglementaire : comparaison des techniques analytiques et/ou des procédés de fabrication entre le dossier d'AMM et les procédures de l'usine
Profil souhaité :
- Pharmacien ou diplôme universitaire Bac +5 en Sciences de la Vie
- Minimum 10 ans d'expérience dans la rédaction et revue du module 2.3 (Quality Overall Summary) et du module 3 (CMC)
- Connaissance et maîtrise des exigences réglementaires CMC pour différents marchés (France, Europe, US)
- Rigueur et autonomie
- Capacité d'analyse et de rédaction
- Bonne capacité de communication interpersonnelle
- Anglais courant exigé
Avantages :
- Management de proximité, ambiance dynamique et stimulante
- Siège de PLG en plein Coeur de la Défense (espaces verts, salle de sport, cantine, salles de co-working, salles de gaming)
- Avantages sociaux (Mutuelle, Carte Ticket Restaurant, Bonus, Congés Payés, Prise en charge du transport, Remboursement des frais liés aux déplacements professionnels.)
- Télétravail possible
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