Analytical Scientist Senior8 monthsUlveston CumbriaUp to ££34,00Are you an experienced Analytical Chemist with strong Method Development experience? Would you like to work for a leading...
Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
- Development of regulatory strategy for key initiatives proposed by the manufacturing part of the business including sourcing changes on the API and Drug Product.
- Provision of regulatory advice to colleagues in the manufacturing organisation.
- Creation and maintenance of regulatory plans.
- Interface with other regulatory departments within Global Regulatory Affairs.
- Preparation/Authoring of regulatory dossiers Market Specific Requests to support key manufacturing initiatives including source changes.
- Identify improvement opportunities for CMC Regulatory processes, policies and systems.
- Provide feedback on progress and challenges to key stakeholders.
- Contribute to the maintenance of global CMC regulatory intelligence.
- Preparation of high quality, Chemistry, Manufacturing and Control detailed regulatory documents using varied information sources.
- Minimum 5 years strong CMC experience - authoring mandatory.
- Be aware of the contents of a marketing authorization application
- Detailed proven CMC Regulatory knowledge and experience for EU, US and EMAP region
- Understands CMC regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
Minimum graduate level, with a relevant biologically based scientific background.
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.