Regulatory Cmc Manager
Due to continued growth a well respected company require an experienced Regulatory Affairs CMC Specialist to take on a newly created Management position. Leading a small core team you will mentor and guide to group to deliver an exceptional customer experience with the highest levels of technical expertise and counsel to their clients. You'll have to opportunity to work on a diverse and exciting range of projects across a wide scope of industry. Based in Clonmel, you'll benefit from an attractive remuneration package, flexible working arrangements and a dynamic, supportive culture. About the Job: 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 analyzing 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. Maintain communication with client and internal teams to ensure that projects are delivered in keeping with our responsibilities to the client. Builds and maintains strong relationships with EU competent authorities to ensure ease of access & influence. Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to the company's products. Supports EU regulatory initiatives and issues as appropriate. About You. BSc (MSc or higher preferred) life sciences, or related field. 7-10 years related experience within Pharmaceutical Regulatory Affairs. Experience with global legislation and regulations relating to medicinal product registration. Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, line extensions and renewals. Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage. Ability to project manage across a diverse and complex portfolio of products and priorities. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
15 days ago