ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
This is a remote/home-based freelance consulting positions with an immediate start and an expected duration through the end of 2020. The Regulatory Affairs Consultant will provide support for regulatory submissions and post authorisation in line with agreed client strategy.
- Project Management of cross-functional team for e.g. CTAs, MAAs, PIPs, Variations, PSURs, DSURs, etc.
- Planning of submissions
- Review of documents for submission
- Provide regulatory expertise and guidance on procedural and documentation requirements to clients. Identify potential regulatory risks and propose options to mitigate these.
- Compilation of submission dossiers, writing and reviewing regulatory documents.
- Undergraduate or Post graduate degree in a life sciences discipline
- Strong project management skills
- Good working knowledge of regulatory submission strategy, identifying submission risks and opportunities, while leading simple to complex regulatory applications and managing procedures through approval
- Keen attention to detail
- Ability to work independently but contribute pro-actively to a project team
All candidates must be legally eligible to work in France.