Senior Regulatory Affairs Officer

On behalf of our client, a Dublin based pharmaceutical company, we are currently recruiting for a Senior Regulatory Affairs Officer. There are hybrid and flexible options available.

Provide regulatory affairs support and manage International MAAs and Lifecycle activities for our current and actively growing range of pharmaceutical products, CAMs, our R&D pipeline products’ therapeutic indications and international markets. Promote and facilitate team and corporate growth and success.

Responsibilities:

·      Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, and ad hoc R&D pipeline)

·      Preparation and filing of submissions including; life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing.

·      Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.

·      Support the strategic and operational planning and registration of CAMs in global markets

·      Actively participates and employs effective communication practices with internal customers (CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, Globally based Regulatory Managers).

·      Prepare status reports and metrics for assigned projects

·      Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.

·      Line manage or supervise junior internal or external team member(s) if needed

·      Promote best regulatory practice and approach in business operations

·      Promote and develop best use of regulatory tools and e-platforms

·      Support Change Control and Quality Management process within GRA

·      Any other duties as assigned on ad hoc basis

QUALIFICATIONS

·      >3 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)

·      Experience of EU DCP and MRP MAAs

·      Experience of emerging markets / international RoW markets and regulatory filings is

·      Quality control review of technical/ regulatory documents

·      Understanding of Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices

·      Publishing: eCTD Office and or NEES – an advantage

·      Effective teamwork track record

·      IT Literate and working familiarity with regulatory publishing platforms

·      Project management experience

For full details contact Linda at +353 1 2784703 or email your CV to [email protected]. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com