Maternity Cover Contract - 12 Months
Flexible working hours available
- Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements;
- Manage international regulatory submissions according to company strategy and ensure registration deadlines are met;
- 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;
- Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines.
- 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
- 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
- Sense of urgency – responding to issues and opportunities in a timely manner
- Intellectual curiosity – willing to suggest and try new ideas
- Positive and pro-active approach to business tasks
- Excellent interpersonal and communications skills.
- A solutions provider with strong multi-tasking abilities
- Manage evolving deadlines effectively with regular feedback and updates.
- Enthusiasm and Drive to take ownership and drive process initiatives.