Regulatory Project Management Consultant

Are you an experienced Regulatory Project Management Consultant? Do you have experience across early development such as pre-clinical scientific advice to project management of dossier preparation for MAA or BLA/NDA filings? If so, this could be the perfect opportunity for you!

We are recruiting for a Regulatory Project Management Consultant to join a leading Regulatory Consultancy business based in Munich on a permanent basis.

This role would need to be onsite for a minimum of 3 days per week. Our client offers full flexibility to manage your own workload within a professional and friendly working environment that is truly unique.

This role does not involve client acquisition.

Responsibilities:

• Manage EU and FDA Marketing Authorisation Application procedures including:
• Preparation of Module 1 documents.
• Assignment and management of team resources.
• Co-ordination of Mod 2 & 3 preparation and finalisation.
• Tracking Modules 4 & 5.
• Preparation and track project plans.
• Interaction with Regulatory Agencies on behalf of clients before, during and after approval.
• Management the MAA procedure on behalf of clients.
• Provide regulatory advice to clients.
• Prepare and manage project plans.
• Request pre-approval Agency interactions on behalf of clients (Scientific Advice, Rapporteur meetings; PRIME requests; FastTrack/ Breakthrough designation requests etc.) including preparation of supportive documentation.

Requirements:

• Master or PhD in Life Sciences, Medicine or Veterinary Medicine.
• At least 10 years Project Management and Regulatory Affairs experience, understanding of FDA and ICH regulations and guidelines.
• Competent with Project Management tools and software.
• Excellent communication skills, strategic thinker, solution orientated.
• Ability to work independently and manage multiple tasks simultaneously under time constraints.
• Flexible with excellent prioritisation skills.

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.