Head of regulatory affairs manager

il y a 4 jours

Rue GardenatLapostol Suresnes France Phagos Temps plein

The Regulatory affairs manager defines and executes the regulatory strategy to secure market access for our personalized phage cocktails, acting as the primary bridge between our R&D and veterinary health authorities (EMA, FDA, national agencies).

Main Responsibilities

  • Prepare and manage submissions: Compile, review, and submit regulatory dossiers for clinical trials and marketing authorizations.

  • Liaise with authorities: Act as the primary point of contact for regulatory agencies (EMA, FDA, ANSES, etc.), managing scientific advice meetings and responding to queries.

  • Ensure compliance in R&D: Collaborate with the Lab  and Production teams to ensure that data generation (safety, efficacy, and manufacturing) meets Good Laboratory/Manufacturing/Clinical Practices (GLP/GMP/GCP).

  • Monitor regulatory intelligence: Stay ahead of evolving regulations regarding bacteriophages and biologicals to influence policy and adapt company strategy.

  • Coordinate external partners: Manage relationships with specialized regulatory consultants and CROs.

  • Manage the budget for submission fees, external consultants, and regulatory memberships.

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