Regulatory Affairs Specialist

Harry Walsh Associates Ltd

Cork

Reporting to the Regulatory Affairs Manager you will have responsibility for monitoring regulatory compliance across multiple territories ensuring a high level of regulatory compliance, supporting regulatory submissions, ensuring product safety and labelling compliance. You will assist in the monitoring of multiple global suppliers to ensure regulatory compliance, generate metrics and prepare reports for the regulatory department. Responsibilities: Perform Regulatory Affairs activities ensuring compliance with applicable regulations and requirements, including but not limited to. - Oversee and contribute to the preparation of regulatory submissions. - Manage submission timelines, monitor approval status and communicate change status to concerned parties in a timely manner. - Prepare, review and/or approval of regulatory change controls, risk assessments. - Respond to Competent Authorities’ queries and deficiencies in a timely manner. Maintain a good understanding of existing and emerging pharmaceutical regulations and provide regulatory direction and support. Monitor and interpret new and existing regulations and guidance’s to evaluate the impact on the business. Liaise effectively with internal departments and external suppliers to support the timely introduction of new products to market. Ensure compliant operation and maintenance of internal processes and systems for accuracy of content. Ensure the effective implementation of a quality management system in the Regulatory function. Preparation of monthly metrics and reports to monitor and cross-compare the quality systems. Be flexible within the Regulatory function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience. Education/Training: Educated to degree level or higher in Chemistry, Microbiology or other scientific discipline. 5+ years FDA regulated pharmaceutical experience; 2-3+ years regulatory affairs experience. Knowledge and Skills: Thorough understanding of regulatory and compliance guidelines within pharmaceutical manufacturing. An understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately. Ability to work independently and make decisions based on judgement and integrity. Proven analytical and problem solving skills and the ability to transfer findings into report and presentation formats. Familiarity with concepts of Regulatory Approval process for generic pharmaceutical products an advantage. Next Steps: Apply now by clicking the “Apply” button below. Not quite ready to apply, or have some questions first? Call Evelyn 021 436 8330 to discuss this role in confidence. “Finding the right job for you....your job your location and your salary!” www.hwa.ie. This job originally appeared on RecruitIreland.com.

2438 days ago