Regulatory Affairs Specialist
hace 2 meses
About the Role
Argenta is seeking a highly skilled Regulatory Affairs Associate to join our team. As a Regulatory Affairs Associate, you will play a crucial role in managing our relationships with leading players in the animal nutrition sector.
Key Responsibilities
- Gain knowledge on relevant EU food chain legislation and apply relevant EU/EFSA guidance documents.
- Learn how to draft technical dossiers and design studies to support them.
- Manage applications through e-Submission Food Chain Platform and post-submission requests from EURL, EC or EFSA.
- Perform feasibility assessments and data audits and keep gap analyses updated.
- Draft protocols and review study reports.
- Perform raw data checks or statistical analysis.
- Liaise with external laboratories and suppliers.
- Notify studies in EFSA Connect Portal and submit Public Access to Documents requests.
- Verify legal status of ingredients.
- Build effective communication with clients and with relevant EU authorities.
- Assist clients with non-EU regulatory requests and follow up with clients after work has been delivered, work towards upselling and managing budgets.
- Improve and develop project management skills to keep internal project management systems up to date.
Requirements
- Flexible with strong interpersonal skills, a can-do attitude, self-motivated and able to work to strict timelines.
- Budget awareness and attention to detail is vital for success in this role.
- Proficient in English communication, both written and verbal.
- Graduate in veterinary medicine, veterinary sciences, animal science chemistry or similar.
- Knowledge of statistics, bioinformatics and toxicology.
- Prior experience in Regulatory Affairs and related to feed additives is a plus.
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