The role:To assist in the preparation of the nonclinical content for various global regulatory dossiers Responsibilities:This role will assist in the preparation of nonclinical...
Preparation of high quality, Chemistry manufacturing and control (CMC) detailed regulatory documents using varied information sources. Liaising closely with other internal personnel to ensure accuracy of such documents. Working together with other groups to ensure that ongoing projects are captured in these documents and that any changes are recorded. Ensuring that project work proceeds according to agreed deadlines and maintaining status records. Responsible for highlighting potential delaying factors promptly.
Role Specific Requirements
- Detailed proven CMC knowledge and experience for primarily EU but will work within the US market also.
- To support in CTA submissions and prepare high quality dossiers.
- Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions
- Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
- Experience in biopharma submissions highly desired
Minimum graduate level, in any life sciences.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.