Regulatory Affairs Manager

Pe Global

Sligo

Currently assisting our client with the recruitment of a Regulatory Affairs Manager in Sligo. This is a full time permanent role which can be worked remotely for the right candidate. The role is responsible for providing global regulatory support for the Plant product portfolio. This will include leadership in developing and implementing CMC regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products. The Role: Submits application for MIA (Marketing or Importer Authorization) to HPRA and maintain MIA current by submitting variations to HPRA as needed. Represents the company when needed as interface with European agencies. Establishes effective working relationships with authorities and agencies. Establishes and maintains effective working relationships with development and business teams. Ensures cross-functional perspectives/expertise is incorporated into regulatory plans prior to decisions being made in cooperation with Israeli team and coordination with Director, Global Vaccine Regulatory Affairs. Analyzes regulatory environment for impact on project/plans and communicates the impact appropriately to RA team and department director. Leads the development and implementation of CMC regulatory strategy supporting both clinical and commercial products. Recognized CMC expert serving as primary project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities. Provides RA-CMC support and advice for all internal activities related to manufacturing, development, control, and quality of products in development in Sligo plant. Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines, and SOPs. Leads with cooperation of the global team submissions in EU and MENA countries all regulatory activities in EU to obtain new EU and MENA licenses. Develops strategy for pre-submission meetings with regulatory authorities to reach agreement on complex CMC requirements. Partner with Manufacturing, Quality, Technical/Analytical Development and Research to develop the CMC CTD content and ensure compliance with global health authority requirements in preparation for licensure. Supports Global licensing processes. Assists Plant manager in all regulatory inspections. Requirements. 10 years + industry experience with at least 8 years of Regulatory CMC experience. BSc in a scientific/technical discipline required. Experience with vaccines would be preferable. Strong Communication skills with the ability to expresses complex ideas clearly/succinctly both in writing and verbally. Strong interpersonal, communication, coaching and training skills. This role will require some travel to MENA region. This role can be worked remotely also. 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.

2022 days ago