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.

• Deep knowledge of Veterinary Medicinal Product regulations

• Experience with biologicals, immunologics, or vaccines (Phage experience is a massive plus).

• Understanding of GMP, GLP, and GCP guidelines.

• Strategic Agility: Ability to navigate “grey areas” where regulations for phages are not yet fully standardized.

• Negotiation & persuasion: Capability to defend scientific data to regulators.

• Rigorous attention to detail: Flawless documentation habits.

• Fluent in English (written and spoken)

• Minimum 5 years in regulatory affairs within the animal health or biotech industry.

• Proven track record of interacting with regulatory agencies

• Master’s degree, PharmD, DVM (Doctor of Veterinary Medicine), or PhD in Life Sciences, Microbiology, or related field.