Regulatory Affairs Manager

JR United Kingdom; Bedford; On-site; GBP 50,000 - 70,000; Full time

Job summary

Une entreprise pharmaceutique innovante recherche un Manager en Affaires Réglementaires pour superviser les activités réglementaires au Royaume-Uni et en Irlande. Ce rôle inclut la gestion des lancements de médicaments innovants, la liaison avec les autorités réglementaires et l'assurance de la conformité avec les processus réglementaires. Les candidats doivent avoir au moins 5 ans d'expérience dans ce domaine.

Qualifications

• Minimum de 5 ans d'expérience en affaires réglementaires dans l'industrie pharmaceutique.
• Connaissances approfondies des processus réglementaires au Royaume-Uni.
• Capacité à travailler dans un environnement dynamique.

Responsibilities

• Fournir une expertise réglementaire pour le Royaume-Uni et l'Irlande.
• Gérer les activités réglementaires au Royaume-Uni et en Irlande.
• Assurer la conformité avec les législations nationales sur les médicaments.

Skills

Communication

Organisation

Gestion de priorités multiples

Job description

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Regulatory Affairs Manager - Pharmaceuticals

As the Regulatory Affairs Manager for the UK and Ireland, you will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance (LPPV) and the National Pharmacovigilance Contact Person.

We are a dynamic and innovation pharmaceutical company, dedicated to bringing groundbreaking therapies to markets. With several exciting drug launches planned over the next 24 months, we are looking for a dedicated and experienced Regulatory Affairs Manager to join our team.

Key Responsibilities:

• Provide UK regulatory expertise to the organization.
• Manage regulatory activities for the UK and Ireland.
• Serve as the LPPV/National Pharmacovigilance Contact Person.
• Ensure compliance with UK regulatory processes and national drug legislation.
• Support the launch of innovative drugs over the coming years.
• Liaise with regulatory authorities and maintain up-to-date knowledge of regulatory requirements.

Qualifications:

• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Expert knowledge of UK regulatory processes and national drug legislation.
• Strong communication and organizational skills.
• Ability to work in a fast-paced environment and manage multiple priorities.
• Proven track record of successful regulatory submissions and product launches.