Main Objective of Role
- Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements;
- Manage worksharing variations for nationally registered products in Europe as per the strategy requested by Senior Management
- Manage international regulatory submissions according to company strategy and ensure registration deadlines are met;
DOSSIER MANAGEMENT
TASKS RELATED TO THE RA PLAN
- Assist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategies.
- Review of regulatory submissions/MAAs for accuracy, completeness and compliance with EU or relevant Health Authority regulations and relevant guidelines; ensure that all specific national requirements are met.
- Compile the hard copy and/or eCTD of the registration dossier (depending on specific in-country registration requirements.
- Prepare, as per internal process, the data needed to make all required registration fees in a timely manner.
- Dispatch the documentation in the appropriate manner in order to deliver it to the relevant Health Authority or local Regulatory Service Provider or local Marketing Authorisation Holder (MAH); ensure the delivery is confirmed.
- Provide regulatory input to product lifecycle planning, including building of renewal plans, assessing the risk related to 'sunset clause' provision
- Work as part of a team dealing with global registrations and provide regulatory support (guidance and strategy) to multi-disciplinary team and all operational departments within the company.
- Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
Job – related work experience required:
- Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
- Min 4-5 year experience in a regulatory affairs environment
- Min 4-5 year experience in the pharmaceutical industry
- Detailed knowledge of EU and other regions current registration requirements for dossier preparation and procedure running
- Solid knowledge of specific national requirements in EU and other regions
For more information and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671
