Regulatory Affairs Associate

Pe Global

Cork

PE Global is currently recruiting for a Reg Affairs Associate for Bio client in Cork : Duties: Regulatory Affairs Senior Associate works with the Regulatory Affairs Associate Director to ensure that the activities that take place and the documentation that is produced within the cGMP environment comply with the necessary regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics to fulfil project objectives. The Regulatory Affairs Senior Associate reports to the Regulatory Affairs Associate Director. Responsibilities Conduct relevant checks to support regulatory cmc queries from various groups across site, Process GMP documentation to support global submissions. Responsible for the timely sourcing and or authoring of documentation to support regulatory submissions worldwide. Assist in the preparation for interactions with global regulatory authorities. Represent regulatory cmc at relevant site meetings. Participate in global teams as regulatory cmc representative for project specific discussions. Responsible for timely sourcing and or authoring of documentation to support regulatory filings and/or correspondence with Regulatory bodies. Proactively identifying issues and suggesting appropriate strategies to mitigate risks. Ensure consistent and appropriate communication within the department and with other functional areas. Interact with global Regulatory partners, internal cross functional teams, and consultants. Participate in cross-functional project teams and work effectively with multiple disciplines and personalities. Experience 5+ years experience in a cGMP regulated environment, with exhibited knowledge or proficiency in CMC Regulatory Affairs or a related function. Candidate should demonstrate initiative and have the ability to work both independently and collaboratively in a team structure. Demonstrated effective problem solving, strong understanding of regulatory affairs submission and management skills and the ability to prioritize multiple tasks are also required. Ability to comprehend technical information related to equipment, processes, and regulatory expectations. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations. Interested candidates should submit an updated CV, marked for the attention of Audrey. audrey.mccarthy@peglobal.net or 00353 21 4297900. 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.

1926 days ago