Senior Regulatory Affairs Specialist

Pe Global

Athlone, Roscommon

Our client based in Athlone is currently looking to recruit a Regulatory Affairs Officer. This role will support activities associated with the registration of company products in Worldwide markets, as well as Regulatory compliance liaison with QA for registered products. The Role: Manage and oversee regulatory strategies and the preparation of regulatory documents targeted for the Irish Market within required timelines. Review and approve regulatory documents (SPCs, PIL and labelling) and implement approved artwork/packaging in line with regulations. Manage all regulatory aspects for new product launches. Prepare regulatory strategies and contribute to business decision making in relation to product launches and product changes. Management and approval of promotional material and advertising. Preparation and submission of product price applications. Prepare and deliver training materials for internal training, and conduct training session on relevant scientific and regulatory topics. Lead investigation is potential non-compliance issues and coordinate with relevant stakeholders and colleagues as necessary. Regulatory surveillance and update of affiliate teams of new or topical issues for consideration. Manage medical information queries from the marketplace and provide timely, scientific responses to enquirers. Act as back-up for pharmacovigilance and quality (product complaints, recalls etc) within the company. Work collaboratively with relevant Global and country teams to establish and implement regulatory strategies within agreed timescales. Advise the local teams on regulatory updates, when required. Requirements. 8+ year’s previous experience within a medical device or pharma business. Degree in Science, Engineering or Pharma is a MUST have. Knowledge of current EU registration and dossier requirements. Team player with ability to work on their own initiative. Be flexible and prepared to work in any required areas. An excellent understanding of change management principles and tools. Must have excellent communication skills both oral and written. If you are interested in this role please email CV to aoife.lomasney@peglobal.net or contact Aoife Lomasney on 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

1921 days ago