Regulatory CMC Dossier Manager (remote)

Job Description
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 #####
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.
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