Regulatory Affairs Project Manager
vor 4 Wochen
Regulatory Affairs Project Manager
Company Overview
Boutique Regulatory Consulting services company
Based in Munich, Germany
Provide their clients a unique and tailor-made support service with European and US regulatory requirements.
Offering expert guidance and know-how to optimise the time to market for your products.
Established for over 15 years and have over 500 clients in Europe, North America, Japan, Australia, and Asia – very international office – giving you
They perform over 150 Scientific Advice meetings per year and have filed more than 50 complete fully electronic submissions to the EMA and FDA in the past years.
Their mission is to ensure that patients get access to good medicines without unnecessary delay.
Primary Objectives:
This position cover project management of regulatory activities from early development, ie pre-clinical scientific advice to Project Management of dossier preparation for MAA, BLA & NDA filings.
Tasks & Responsibilities:
Manage EU and FDA Marketing Authorisation Application procedures including:
Preparation of Module 1 documentation.
Assignment and management of team resources.
Co-ordination of Module 2 & 3.
Tracking Modules 4 & 5.
Preparation and Track Project Plans.
Interaction with Regulatory Agencies on behalf of Clients before, during and after approval.
Management of MAA procedures on behalf of clients.
Provide Regulatory Advice to Clients
Prepare and manage project plans.
Request scientific advice meetings on behalf of clients including preparation of supportive documentation.
majority of our work is pre-approval
we are focussing primarily on novel products.
Reg project management 8-10+ years.
Manage EU and FDA Marketing Authorisation Application (MAA) and BLA (biologics experience).
Pre-approval experience in regulatory requirements for development of novel products, NAS, Biologics, ATMPs, Gene therapies
Regulatory advice to clients.
Regulatory clinical experience.
A minimum of 3 days per week (every week) is a must.
Such candidates are most likely currently working in biotech companies.
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