Regulatory CMC Associate (hybrid)

Proclinical is seeking a Regulatory CMC Associate for a 12-month contract role. This position will provide support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across various phases of product development, from clinical to lifecycle. The role involves organising, managing, and executing regulatory CMC projects and submissions, and may include tasks such as creating and maintaining submission timelines, formatting documents, scheduling meetings, and managing document reviews.

Responsibilities:

• Provide support to the CMC function in regulatory submissions.
• Organise, manage, and execute on regulatory CMC projects and submissions.
• Create and maintain submission timelines and tables of contents.
• Format documents per style guide.
• Schedule and draft agendas for meetings.
• Manage document reviews.

Key Skills and Requirements:

• Proficiency in Microsoft Office suite, especially Word, Excel, PowerPoint, and Project.
• Strong organisational skills with attention to detail.
• Excellent time management skills and ability to prioritise workload.
• Project management skills.
• Strong interpersonal and communication skills (both verbal and written).
• Ability to work both independently and as a member of a team.
• Degree in life sciences, biochemistry, or chemistry (preferred).
• Experience in the biopharmaceutical or pharmaceutical industry (preferred).
• Familiarity with eCTD structure (preferred).
• Motivated with initiative to learn quickly.
• Experience in CMC, including preparation of submissions to Agencies (preferred).

If you are having difficulty in applying or if you have any questions, please contact Dracen Black at d.black@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