Description
CMC Specialist is required to work with a team of Regulatory Affairs experts to assist or prepare high quality documentation for regulatory submissions (variations, renewals, annual reports, labelling changes andmost importantly Clinical Trial Applications). The focus of this contract is CMC variation experience and the ideal candidate will have experience of routine maintenance of chemistry manufacturing controls.
Key responsibilities and goals
Ensure accuracy, scientific validity and optimal presentation of submission or regulatory documents that meet current best practice standards. To provide regulatory advice to teams on assigned projects. To identify regulatory issues and resolve with relevant departments or country office. To communicate with Regulatory Authorities to expedite review and approval of submissions.
Aware of and comply with all applicable Quality Manual, Quality Management System, Quality Management Policy, Quality Goals. Complete all planned Quality and Compliance training within the defined deadlines. Identify and report any quality or compliance concerns and take immediate corrective action as required. Maintain an up-to-date knowledge and understanding of current regulatory requirements within area of responsibility, including pharmacovigilance requirements.
Regulatory Affairs expertise is essential to act as a subject matter expert in the field of CMC as well as experience in submitting Clinical Trial Applications to regulatory authorities. Strong analytical skills and Ability to prioritize, plan and evaluate deliverables. Relevant experience in the pharmaceutical industry; experience in regulatory regulatory affairs, and preferably, some experience of negotiating directly with local regulatory authorities. Ideally will be familiar with continuous improvement methodologies such as Lean and Six Sigma.
Please apply through this advert or call Billy for more info.