A leading French Pharmaceutical client with global RA, PV, Clinical, and Quality teams based out of Dublin, are expanding their regulatory affairs team and are looking for a new Senior RA Officer.

This organisation are going through an exciting period of growth and development, with a strong product portfolio and R&D pipeline, it is an excellent time to join the business and gain experience in and exposure to global markets and innovative, specialist products in important therapeutic areas.

The Role

Working alongside an RA Manager, the Senior Officer's duties will include:

• Acts as responsible Regulatory Team member for assigned regulatory projects.
• Preparation of submissions including CMC variation filling, initial MAA filling, labelling updates, renewals, Marketing Authorisation Transfers (MATs), CMC authoring and \ or updates as required.
• Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
• Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).
• Understands the Scope of Work, timelines and deliverables for a given project.
• 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.
• Learn, develop and train junior colleagues.

The Person

The successful candidate will have:

• A minimum of a BSc in a Science related discipline and 3+ years RA experience in Human Health.
• Experience with:

• Lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).
• Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.
• EU DCP and MRP MAAs.
• Emerging markets / international RoW markets and regulatory filings.
• Quality control review of technical/ regulatory documents.
• Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices.
• Publishing: eCTD Office and or NEES - an advantage.
• Pharmaceutical artwork review and sign-off.

• Positive can-do attitude in growing company with expanding range of therapeutic product range.
• Good team player with local Dublin based and internationally based colleagues.

Contact Helena Boyle on (01) 6321870 for a confidential discussion.