This global speciality pharmaceutical organisation are seeking an experienced Senior Regulatory Officer Submissions to join the International Submissions team based at their offices in Citywest, Dublin. Reporting to the Head of Regulatory Affairs Europe, this person is responsible for managing international regulatory submissions according to company strategy and ensuring registration deadlines are met.
Duties and responsibilities of the Senior Regulatory Officer Submissions will include but are not limited to:
- Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards
- Manage work sharing variations for nationally registered products in Europe
- Manage international regulatory submissions
- Respond to Health Authorities' queries and deficiencies in a timely manner
- Liaise with other departments to support the timely introduction of new products into markets
- Work as part of a team dealing with global registrations and providing regulatory support to all operational departments within the company
- Compile the hard copy and/or eCTD of the registration dossier
- Submit Marketing Authorisation Applications (MAA) to Health Authorities according to the registration plan and company's registration strategy
- Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner
- Assist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategies
- Build departmental awareness of local regulatory requirements in global markets
To be considered for this position you will have skills and experience in the following:
- BSc and 4+ years pharma/bio industry experience in a Regulatory capacity
- 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
- Knowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.)
- Results and performance driven - deliver results that meet or exceed expectations
- Excellent interpersonal and communications skills
- A solutions provider with strong multi-tasking abilities
- Manage evolving deadlines effectively with regular feedback and updates.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.