Cache of job #13619893

Job Title

Regulatory Affairs Officer

Employer

Hartley People

Location

Waterford, Tipperary, Cork

Description

Would you like to work in a company where every day is an opportunity to create change, master new skills and make a difference? This is an exciting opportunity for a Regulatory Affairs Officer to join a regulated manufacturing company based in Co. Waterford with whom Hartley People work with on an exclusive basis. This is a contract role and the location is an easy commute from Clonmel, Dungarvan, Cahir and Carrick On Suir. The Role: • Prepare and review regulatory documentation for submissions in Europe and other overseas territories. • Provide project specific Regulatory Affairs strategy, technical expertise and co-ordination oversight for regulatory projects. • Ensure quality performance for regulatory projects. • Liaise with internal departments and external customers to support company projects. • Develop working relationship with people throughout the company, with regulatory personnel in other companies, with clients and with the regulatory authorities. • Ensure compliance with relevant organizational and Regulatory Affairs Standard Operating Procedures. The Person: • Third level scientific qualification to degree level. • Minimum of two years experience in a similar role. • Good knowledge of regional/national country requirements/Regulatory Affairs Procedures. • Authoring CTD dossiers for MA applications and post-approval regulatory submissions. • Regulatory submission experience in marketing authorisation applications. • Preparation of product information for post-approval regulatory submissions. • Electronic submissions to regulatory agencies. • Expert knowledge of European and global regulatory guidelines. • Excellent English language skills. • Effective oral and written communication skills. • Good organizational and planning skills. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent. For immediate consideration please call Pairic on 051-878813 or email your CV in a word document to pairic@hartleypeople.com. Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Manager, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist.

Date Added

2673 days ago

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