Regulatory CMC Dossier Manager (remote)

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