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* Tullyvin, Cootehill, County Cavan
* Negotiable
* Permanent | Full Time
* Contact name: Univet
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Executive is responsible for the day-to-day Regulatory Affairs activities within the department.
Key Requirements
* Prepare, compile, and submit new product applications through national, mutual recognition, or decentralised procedures.
* Update dossiers to mutual recognition standards and progress through various regulatory procedures.
* Respond to queries from regulatory agencies on new and existing products in collaboration with relevant personnel.
* Prepare renewal and variation applications to support changes to authorized details.
* Handle raw material supplier submissions, review Active Substance Master Files, and CEP reviews.
* Discuss, procure, and review audits of raw material suppliers.
* Update product literature according to regulatory and marketing requirements.
* Communicate with partner companies and distributors, providing necessary documentation.
* Coordinate with relevant departments on registered details changes.
* Provide regulatory compliance information related to change control, packaging, product literature, and PQRs.
* Maintain regulatory information filing and retrieval systems.
* Stay updated on regulatory legislation and trends to guide internal and external stakeholders.
* Perform other duties as assigned by the Regulatory Affairs Manager.
This job description is not exhaustive; additional duties may be assigned as needed, and activities may evolve over time.
Essential Requirements
* Bachelor’s Degree in a scientific field (Pharmacology, Chemistry, Biology, Veterinary, or similar).
* 3-4 years of Regulatory Affairs experience in the Pharmaceutical or related industry.
* Ability to multitask effectively.
* Excellent attention to detail and communication skills.
* Strong organizational skills with the ability to prioritize and manage projects.
* Good interpersonal skills for stakeholder engagement.
* Self-motivated with initiative and resourcefulness.
Desirable
* Post-graduate education in Pharmaceutical Technology, Regulatory Affairs, or Chemistry.
* Proven ability to meet deadlines and work independently.
* Experience in the Agriculture/Veterinary industry is a plus.
Additional Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Business Development and Sales
* Industries: Non-profit Organizations
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