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Regulatory CMC Dossier Manager (remote)
    
        
        £65 - £75 per hour
    
- Contract
 - CMC
 - United Kingdom
 
London, England
        
            Posting date: 
        19 Mar 2024
    
    
        59544
This vacancy has now expired. Please see similar roles below...
Proclinical 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.
 
Key Skills and Requirements:
- 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.
 
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#Regulatory