This is a rare opportunity to join a young, exciting biotechnology company.
Our client is a global specialty pharmaceutical company that focusses on acquiring prescription medicines across a broad range of therapeutic areas in international markets. The company focusses its resources on acquiring and optimizing established medicines.
Rapid expansion has led to the need to create the appointment of Head of Regulatory Affairs to be based in their Dublin office.
Job Spec :
- 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
- Marketing authorisation preparation
- Support to the Regulatory Lead in the preparation of Regulatory documentation for MAA/BLA
- 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
- Provision of regulatory support to Supply Chain, CMC, QA, Safety and Clinical Operations as necessary
- Lifecycle Management of MAs
- Bachelor of Science or higher in a life science
- Minimum of 6 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 (<20%)
- 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 email@example.com 01 2302400