Regulatory Affairs Associate

PE Global is currently recruiting for a Regulatory Affairs Associate (CMC) for a leading multi-national Biotech client based in Uxbridge.

This is an initial 12 month contract with strong possibility of extension for the right candidate.

This role is based in Uxbridge and is a hybrid role requiring the worker to attend the site usually twice a month or as/when required.

CMC submissions globally, compiling submissions for all countries for clinical trials and marketing applications. Lots of work with strict timelines, working well stakeholders and timeline pressures.

Role:

• Provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle.
• Support may include organizing, managing and executing on regulatory CMC projects and submissions.
• Tasks may include creating and/or maintaining submission timelines and tables of contents, formatting of documents per style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested

Requirements:

• Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
• Strong organizational skills with attention to detail;
• Excellent time management skills and ability prioritize workload;
• Project management skills;
• Adept 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
• Candidates need to be able to demonstrate a proactive nature
• Manager is open to graduates with limited experience, the IDEAL candidate would have 1-year regulatory experience in a similar role
• Experience in biopharmaceutical or pharmaceutical industry is an advantage
• Familiarity with eCTD structure is an advantage
• Motivated with initiative to learn quickly
• Experience in CMC, including preparation of submissions to Agencies is advantageous

Interested candidates should submit an updated CV.

Please click the link below to apply or alternatively send an up to date CV to Jennifer.horgan@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***