Regulatory Affairs Technical Specialist
Our Client is a recently established pharmaceutical company, based in Dublin North. They focus on the development and manufacture of generic pharmaceutical products. They are recruiting an experienced permanent full time regulatory affairs professionals to join their team. This role is perfect for ambitious people who are looking to join a company who offers excellent opportunities for training and development along with a competitive package for the right candidate.
This role reports directly to the Head of Regulatory Affairs.
Responsibilities will include:
- Preparation and review of high quality, Chemistry Manufacturing and Control (CMC) detailed regulatory documents for dossier submission
- Liaising and working closely with other company personnel (R&D, Quality, Business Development and Licensing) to ensure accuracy of such documents
- Submission of MAAs (generic/bibliographical) in the EU via national, MRP, DCP routes
- Provide regulatory support for out-licensing activities in EU and non-EU territories
- Auditing registration dossiers for the EU in order to evaluate and identify any possible deficiencies prior to assessment
- Liaising with Regulatory Authorities and Affiliates
- Mentoring and daily oversight of Regulatory Affairs Associates and Officers
- Managing post-licensing activities (variations, renewals, PSURs, etc.)
The role will require you to possess a relevant life science or pharmacy degree; you should have a minimum of 5 years EU pharmaceutical regulatory affairs industry experience. Previous exposure to formulation development, CMC and CTD Dossiers for MAA''s is essential. Working knowledge of eCTD is an advantage but not essential.
The role is largely European in geographic scope, but some International areas are involved.
You should be an organised, motivated and approachable team player who also works well independently. You should also have excellent attention to detail.
This role is a great opportunity for an experienced regulatory professional with strong CMC experience to learn and develop within a fast growing and exciting new pharmaceutical company in Ireland.
CV and cover letter to Laurentina Kennedy at The RFT Group email@example.com 01 2302400 / www.rftgroup.ie
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