Regulatory Affairs Executive
- Tullyvin, Cootehill, County Cavan,
- Permanent | Full Time
- Contact name: Univet
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Executive Officer is responsible for the day to day Regulatory Affairs activities within the Regulatory Affairs Department.
- Prepare, compile and submit, new product applications through national, mutual recognition or decentralised procedures
- Update dossiers to mutual recognition standard and progress 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.
- Preparation of renewal applications.
- Preparation of variation applications to support changes to authorised details.
- Preparation of raw material supplier submissions, review of Active substance master files, CEP review;
- Discussion/Procure and review of audits of existing and new raw material suppliers.
- Preparation and/or updating of product literature in accordance with regulatory and marketing requirements.
- Interaction with partner companies, distributors and provision of the required documentation.
- Clear communication with relevant departments regarding the changes in registered details.
- Provide regulatory compliance information within the company in relation to change control, packaging specification, 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.
- Post-graduate education in Pharmaceutical Technology, Regulatory Affairs or Chemistry is desirable.
- Excellent organisational skills along with a proven ability to meet deadlines. · Meticulous approach, attention to details with a commercial insight and excellent communication and negotiation skills with the ability to work under his/her own initiative and as part of a dynamic regulatory affairs team
- Previous Experience within the Agri / Veterinary Industry would be a distinct advantage.