Job Description
EU Regulatory Affairs Manager (Dublin)
This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.
Our client is focused on the discovery, development and commercialization of novel antibodies that are directed towards diseases that involve protein misfolding or cell adhesion. Rapid expansion has led to the need to create the appointment of EU-based Regulatory Affairs Manager, to be based in their Dublin office.
Reporting to the EU Regulatory Affairs Lead, and according to the directives of the company leadership and management, and in accordance with the regulations, the established procedures and the planned objectives, the EU Regulatory Affairs Manager will be responsible for preparing, managing and executing regulatory activities for drug products in Europe and Rest of World (RoW) in compliance with applicable current regulations and standards.
Job Spec :
- General
- Identifies project needs, tracks project timelines and implements team requests
- Reviews documents for regulatory completeness, consistency and accuracy, interacts with project team members to assure completeness, as necessary
- Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with the Regulatory Affairs Lead
- Assists with project management and project administration tasks as required by the project including but not limited to regular status reports and CTA/LCM tracking
- Maintain current knowledge of central and national regulatory requirements in Europe and Rest of World
- Clinical Trial Applications
- Preparation of CTA packages for EU + RoW submissions
- Review and QC of key clinical trial Regulatory deliverables
- Management of vendors/CROs and maintenance of working relationship
- Review and input on Regulatory submission strategy for CT Amendments and notifications
- Marketing authorisation preparation
- Support to the Regulatory Lead in the preparation of Regulatory documentation for MAA/BLA
- Lifecycle Management of MAs
- Input to the variation classification strategy
- Preparation of variations to marketing authorisations
- Support in the submission of SOs or FUMs linked to product MA and RMP
- Collaboration:
- Provision of regulatory support to Supply Chain, CMC, QA, Safety and Clinical Operations as necessary
Person Spec :
- Bachelor of Science or higher in a life science
- Minimum of 4 years relevant Regulatory experience
- Experienced with CTAs (Clinical Trial Applications) submission and maintenance
- Knowledge of EMA Procedures (Centralised Procedure, OMP, PIP etc.) is an advantage
- Knowledge of electronic submissions and e-submission portals (CESP, Eudralink, EMA Gateway)
- Working knowledge of eCTD
- Post marketing/ life-cycle management experience (Variations, Renewals and Labelling)
- CMC Regulatory experience (biological CMC is an advantage)
- Project management experience
- Travel may be required occasionally (<10%)
- Fluent in English both spoken and written
- Must possess excellent interpersonal skills
- Must have the ability to build and maintain positive relationships with management, peers, and direct reports
- Ability to build/forge relationships with key parties (e.g., Competent Authorities, Vendors)
- Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required.
Cv to gerry@rftgroup.ie 01 2302400