Regulatory Affairs Specialist

hace 2 meses


Barcelona, Barcelona, España Argenta A tiempo completo

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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