Regulatory Affairs CMC Manager
Thornshaw Recruitment – Tipperary – On behalf of my client we are sourcing a candidate for the role of Regulatory Affairs CMC Manager. This is a permanent role. PURPOSE / KEY RESPONSIBILITIES: Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies Review the preparation of CMC components for filings and assess fitness of purpose for submission in the relevant countries Gathering, consolidating and analysing regulatory intelligence for the EU & ROW territories and support its application to product-specific activities Ownership/ regulatory responsibility for a portfolio of products for nominated client; via a range of regulatory activities including submission of new marketing authorization applications, variation applications and renewals. Work with the Managing Director and Project Manager to ensure that client deadlines are met and that appropriate resources are allocated to the various projects Mai… – Permanent – Full-timeApply for this job.