Regulatory CMC Dossier Manager (remote)
Proclinical
- United Kingdom
- £65.00-75.00 per hour
- Contract
- Full-time
- Job type:
CMC * Location:
United KingdomLondon, EnglandPosting date: 19 Mar 2024Reference: 59544Proclinical is partnering with a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis with the ability to work remotely from anywhere in the UK. The opening position available is for a Regulatory CMC Manager who is solely focusing on dossiers.Responsibilities:
- Interface directly with CMC/Tech team members, Regulatory, external service providers, and internal stakeholders.
- Influence or persuade others to accept new ideas, approaches, or concepts.
- Manage several complex projects with potentially accelerated or standard priority.
- Act as a mentor to one or more individuals- Contribute to dossier strategy and product development plan creation.
- Lead and supervise dossier authoring activities for early and late-stage projects.
- Identify business improvement areas and drive implementation of improvements.
- Develop process and business improvements within own functional organisation.
- Strong background in Gene therapies, Technical Dossier Writing, and Development.
- Ability to work independently and resolve cross-functional issues.
- Excellent team working skills and ability to coach/mentor others.
- Proven ability to manage complex projects and programs.
- Educational background: PhD with Post-doc experience or University degree with significant relevant experience.