Regulatory Market Compliance Specialist Job in Limerick
Regulatory Market Compliance Specialist
Responisbilities
* Monitor Regulatory Intelligence for local Market updates on a monthly basis, communicating and implementing changes
* Support implementation of Compliance programs in individual regions
* Execute training of personnel on new regulatory requirements
* Responsible for identifying and implementing New Market regulatory requirements for new product launches
* Management of local country consultants where required and conducting audits in association with quality where required
* Responsible for Drug Pricing and Reimbursement including identifying local requirements, preparation of submissions and follow-up on requests.
* Report on current status of Regulatory Compliance to Senior Management on a routine basis
* Support audit program for Compliance Department
* Represent during external regulatory inspection as required.
Educational QUalifications Required
* Bachelor's Degree or Higher in a related science discipline and a minimum of five (5) years plus related experience
* Demonstrated knowledge and application of EU, AU and International and local country specific Pharmaceutical regulations / guidelines
* Experience in Pricing / Reimbursement of Drugs in EU/AU and International Markets
* Excellent interpersonal skills, communication skills (written and oral), customer focus and attention to detail
* Ability to function in a rapidly changing environment and be able to balance multiple priorities simultaneously
* Strong planning and organizing skills
* Responsible for the country specific regulatory compliance activities in. Establishment and maintenance of processes and systems to ensure that all country specific elements relating to the launch of new drugs and maintenance of current products are in compliance with current local regulatory requirements.