Key Role Specific requirements:
- Maintenance of approved Marketing Authorisation (MA) dossiers through submission of variations, renewals, follow-up measures using Vnees.
- Preparation of new MA through national, Mutual Recognition or Decentralised procedures;
- Preparation of responses to queries from regulatory agencies on new and existing products in conjunction with relevant personnel.
- Prepare and/or update product literature in accordance with regulatory or marketing requirements and ensure compliance with the relevant MA.
- Interaction with partner companies, distributors and provision of the required documentation.
- Clear communication with relevant departments regarding the changes in registered details.
- Update internal data bases with changes and the status of on-going tasks.
- Provide regulatory compliance information within the company as regards change control, packaging specifications, product literature and Product Quality Review requirements.
- File and retrieve regulatory information in the existing filing system.
- Keep up to date on information on regulatory websites as regards new guidelines, fees and application documents.
- Ability to perform via multitasking and be a good self-starter.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
- Bachelor’s Degree in science.
- A working knowledge of European pharmaceutical regulations, Directives and guidelines.
- Ability to multitask.
- Excellent attention to detail.
- Excellent verbal and written communication skills.
- Good knowledge in Microsoft office.
- Post-graduate education in Pharmaceutical Technology, Regulatory Affairs or Chemistry is desirable.
- 1-2 years’ experience in the field of Regulatory Affairs, R&D, Analytical Method Development, Quality Assurance, Quality Control within the Pharmaceutical or related industry would be a distinctive advantage.