Den Jobinserenten von Leaman Life Sciences direkt kontaktieren
Callum Costello
Finding the 'Needle in the Chaystack' talent
An exciting opportunity to join a well-known regulatory consultancy in Europe that boasts the opportunity to support several regulatory activities for Pharmaceutical and Biotech Clients globally
The Regulatory Project Manager will play a pivotal role in ensuring that regulatory activities from early development through to dossier preparation for MMA and/or BLA/NDA filings.
Key Responsibilities:
Manage EU and FDA Marketing Authorisation Application procedures including:
Preparation of Module 1 documents
Co-ordination of Modules 2 & 3
Tracking Modules 4 & 5
Interact with Regulatory Agencies on behalf of clients
Manage the MAA procedure on behalf of clients
Key Requirements:
Masters or PhD. in life sciences
At least 6-8 years Project Management and Regulatory Affairs experience
Understanding of FDA and ICH regulations and guidelines
Karrierestufe
Management
Beschäftigungsverhältnis
Vollzeit
Tätigkeitsbereich
Wissenschaft
Branchen
Forschungsdienstleistungen, Biotechnologieforschung und Arzneimittelherstellung
Mit einer Empfehlung lassen sich Ihre Chancen auf ein Vorstellungsgespräch bei Leaman Life Sciences verdoppeln.