Head of regulatory affairs manager
il y a 12 heures
Head of Regulatory Affairs Manager – Phagos Join to apply for the Head of Regulatory Affairs Manager role at Phagos. 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. Profile Requirements 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. About Phagos Phagos is on a mission to create a cleaner, more sustainable future by 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. Location: Suresnes, Île-de-France, France. Employment Type: Full-time. Seniority Level: Mid-Senior Level. Job Function: Legal. #J-18808-Ljbffr
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Head of regulatory affairs manager
il y a 21 heures
Rue Gardenat-Lapostol, Suresnes, France Phagos Temps pleinThe 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 ResponsibilitiesPrepare and manage submissions: Compile, review, and submit regulatory dossiers for...
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Head of Quality Affairs and Regulatory Affairs | Permanent Contract
il y a 2 semaines
Suresnes, France Hepta Medical Temps pleinLa mission The company: Hepta Medical is a French medical device company developing an minimally-invasive treatment for lung cancer. Their device is a flexible microwave ablation probe which can be introduced in the patient’s lung through the airway to locally ablate and destroy the tumor. During the procedure, their system is capable of locally measuring...
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Regulatory Affairs Coordinator Zone Latam
il y a 2 semaines
Suresnes, France Spot On Sp. z o.o Temps pleinPrimary Responsibilities Within our site of Suresnes (France) - Contributes to recruitment of the staff dedicated to these projects/programs in the Hub/Platform zone - Ensures delivery of regulatory activities by the Hub/Platform zone, on assigned programs/ projects. Serves as the senior contact for regulatory issues (backed up by regulatory colleagues as...
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Suresnes, France Hepta Medical Temps pleinOverviewLa missionThe company :Hepta Medical is a French medical device company developing an minimally-invasive treatment for lung cancer. Their device is a flexible microwave ablation probe which can be introduced in the patient’s lung through the airway to locally ablate and destroy the tumor. During the procedure, their system is capable of locally...
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Global Director, Neurology Patient Affairs
il y a 7 jours
Suresnes, France Servier Group Temps pleinAn international pharmaceutical organization is seeking a Global Patient Affairs Director – Neurology to drive patient engagement strategies related to rare neurological disorders. Ideal candidates will have at least 7 years of leadership experience in patient advocacy and a strong background in neurology. Responsibilities include defining project...
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Regional Patient Affairs Director
il y a 7 jours
Suresnes, Île-de-France SERVIER Temps pleinDate de parution: 31 oct. 2025Ville: SuresnesPays/Région: FRType de contrat: CDIN° offre: 10266Regional Patient Affairs Director - LATAM RegionWe are a human-scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "committed to...
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Regional Patient Affairs Director
il y a 7 jours
Suresnes, Île-de-France SERVIER MONDE Temps pleinWe are a human-scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "committed to therapeutic progress for the benefit of patients."As a global leader in cardiology, we aim to become a focused and innovative player in oncology by...
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Regional Patient Affairs Director
il y a 7 jours
Suresnes, France Servier Group Temps pleinRegional Patient Affairs Director - LATAM Region We are a human-scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us fully serve our mission: "committed to therapeutic progress for the benefit of patients." As a global leader in cardiology, we aim to become a...
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Regional Patient Affairs Director
il y a 12 heures
Suresnes, France Servier France Temps pleinRegional Patient Affairs Director - LATAM Region Date de parution: 19 déc. 2025 Ville: Suresnes Pays/Région: FR Type de contrat: CDI N° offre: 10266 We are a human‑scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "committed...
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Regional Patient Affairs Director
il y a 11 heures
Suresnes, France Servier Temps pleinJoin Our Team as a Regional Patient Affairs Director - LATAM Who are we? 22,000 passionate individuals from over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, motivated by the desire to care, to dare, to grow, and to commit to being useful to those in need. Come and experience...
