Head of regulatory affairs manager

Job description

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.

Preferred experience

* 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.

Who are they?

Phagos is on a mission to end bacterial disease.

We are using bacteria’s natural predator, the bacteriophage, to win the fight against antibiotic resistance and cure infectious diseases. We use breakthrough technologies in both the wet lab and dry lab to generate customized treatments for pathogenic diseases at an unprecedented speed.

The perks & benefits

* Employer-paid health insurance
* Between 2-3 days at home
* Full pay on 1st day of sick leave
* Sports allowance
* Paid industry certifications
* Generous PTO