Key role requirements:
- Prepare, compile, and submit, new product applications through national, mutual recognition, decentralised or centralised procedures.
- Prepare, compile and submit variation applications to support changes to authorised details and manage applications through to completion for national, mutual recognition, decentralised or centralised procedures.
- Prepare, compile and submit renewal applications in accordance with strict deadlines, and manage application through to completion.
- Update dossiers to mutual recognition standard and progress through national, mutual recognition, decentralised or centralised procedures
- Preparation of responses to queries from regulatory agencies on new and existing products in conjunction with relevant personnel.
- Collect, collate, and evaluate scientific data, and present the information in an organised format.
- Preparation and/or updating of product literature in accordance with regulatory and marketing requirements.
- Liaise with Regulatory Authorities and external customers/distributors.
- Interaction with partner companies, distributors and provision of the required documentation.
- Work closely with all departments, providing regulatory support for the operation and control of the facility.
- Contribute to cross-functional project teams.
- Clear communication with relevant departments regarding the changes in registered details.
- Update / maintain internal databases in relation to the status of on-going tasks.
- Provide regulatory compliance information within the company in relation to Change Control, Packaging Specifications, Product Literature, and Product Quality Review requirements.
- Filing and retrieval of regulatory information.
- Keep abreast of all regulatory legislation and trends in order to provide appropriate guidance / direction to internal and external stakeholders on all areas of regulatory compliance.
- Any other tasks as may be reasonable requested by the Regulatory Affairs Manager.
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 received in scientific area (Pharmacology, Chemistry, Biology, Veterinary or similar).
- At least 3-4 years’ Regulatory Affairs experience within the Pharmaceutical or related industry.
- Ability to perform via multitasking.
- Excellent attention to detail.
- Excellent verbal and written communication skills.
- Excellent organisational skills with the ability to prioritise and manage projects within a team environment.
- Good interpersonal skills, building strong working with relationships with stakeholders both internal and external.
- Self-motivated with the initiative and resourcefulness to successfully see projects through to completion.
- Proficient in the use of MS Office tools.
- Post-graduate education in Pharmaceutical Technology and Regulatory Affairs desirable.
- Previous Experience within the Agri / Veterinary Industry would be a distinct advantage.
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.