Senior Regulatory Officer - Submissions
- Experience Level
- Experienced (non-manager)
Compensation: Competitive total compensation.
We have a newly created vacancy for a permanent Senior Regulatory Officer - Submissions. You will be responsible for managing international regulatory submissions according to company strategy and ensuring registration deadlines are met. In addition, you will be expected to attend regulatory strategy or submission meetings with Health Authorities. You will also have the opportunity to 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.
As Senior Regulatory Officer, you will be a flexible, results and performance driven individual, with intellectual curiosity and exceptional interpersonal skills. An ability to work autonomously and possession of problem-solving skills is essential. You will also possess good cultural awareness and sensitivity, with a good understanding of the need for confidentiality when relevant.
This position will be located outside Dublin city center.
Our client is a global specialty and branded pharmaceutical company, improving the health of patients across the world through their high quality and affordable medicines.
Main Duties and Responsibilities:
- Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements.
- Manage work-sharing variations for nationally registered products in Europe as per the strategy requested by Senior Management.
- 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.
- Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner.
- Communicate Health Authority approvals/final decisions to the relevant departments.
- Build departmental awareness of local regulatory requirements in global markets.
- Assess the impact on existing files when new regulatory requirements are issued.
- Archive the registration documentation according to internal standards; introduce and regularly update the internal RA database.
· Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
· Minimum 4-5 years' experience in a regulatory affairs environment
· Relevant experience in, and general knowledge of, the pharmaceutical industry
· Knowledge of EU and other regions current registration and dossier requirements
If you feel this description is something that fits your professional background and character, please apply now, or contact the team at Wentworth Life Sciences.