Regulatory Project Manager

JR United Kingdom; Reading; Remote; GBP 55,000 - 75,000; Full time

Job summary

Un fournisseur de solutions réglementaires leader cherche un Responsable de Projet Réglementaire pour rejoindre leur équipe dynamique. Le rôle implique la gestion de soumissions réglementaires majeures dans les domaines pharmaceutiques et médicaux, nécessitant une expertise en gestion de projets et une solide expérience en affaires réglementaires. Les candidats doivent avoir un diplôme en sciences de la santé et une expérience prouvée en gestion de projets pour réussir dans cet environnement rapide et collaboratif.

Benefits

Opportunités de formation continue

Environnement de travail collaboratif

Qualifications

• Min. 4 ans d'expérience dans le domaine réglementaire.
• 2 ans de compétences avérées en gestion de projets.
• Expérience avec les soumissions majeures US/EU est préférée.

Responsibilities

• Gestion des groupes de travail de soumission (SWG) et supervision des réunions.
• Élaboration et mise à jour des plans de projet réglementaire.
• Management de l'équipe de réponse rapide (RRT) sur les soumissions.

Skills

Analytical Thinking

Interpersonal Skills

Project Management

Multitasking

Education

Bachelor’s degree in Pharma / Medical

Tools

Microsoft Project

Microsoft Office

Job description

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Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team:

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

? To Apply:

Please apply to this job post or you can visit our Careers page for more openings

Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Title : Regulatory Project Manager

Location : Remote ( Base location should be in EU, preferably in UK/ Hungary/ Poland / Romania/ Czech/ Croatia)

Experience : 5 years in Medicinal Products Regulatory Affairs with 2 years in Project Management.

Must have experience:

• US / EU Major submissions Experience
• Hands on exp with IND/NDA/BLA
• PM experience - MS Projects
• SWG Meeting management( Driving cross functional Team meetings)

Key Responsibilities:

Submission Working Groups (SWG) management of –

• SWG Kick Off Meetings
• Recurrent SWG Meetings
• Detailed Regulatory Timelines
• Risks, Actions, Issues, Decisions (RAID) log
• Rapid Response Team (RRT)
• Lessons Learned log, as applicable

Global Regulatory Teams (GRT) management of -

• Meetings support, as required.
• Regulatory Project Plan (RPP)
• GRT Goals
• Risks, Actions, Issues, Decisions (RAID)

Independently leading additional Non-SWG submission types

Requirements:

• Bachelor’s degree in Pharma / Medical or another associated scientific discipline OR equivalent
• Min. 4 years of experience in the Regulatory field and 2 years of demonstrated project management skill sets (required)
• Experience working with Microsoft Project or equivalent program (preferred).
• Experience in driving/supporting submissions for major markets - US, EU, etc. (e.g. IND, NDA, BLA, EU MAA, EU variations, etc.) would be preferred.
• Strong conceptual and analytical thinking skills.
• Ability to work under deadlines and fast-paced work environment.
• Excellent business collaboration/interpersonal skills.
• Intermediate proficiency in Microsoft Office products such as Word, Excel, and Outlook.
• Ability to multitask and prioritize competing assignments.