A leading specialist 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 to join the business on a permanent basis.
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 while working in a very project manager style position.
The Role
Working alongside the RA Manager, some of 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 a growing company with an 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.
