Regulatory Affairs Specialist

hace 2 semanas


Guadalajara, Jalisco, México Phibro Animal Health Corporation A tiempo completo

Job Title: Regulatory Affairs Specialist

Job Summary:

The Regulatory Affairs Specialist plays a key role in ensuring the maintenance of the product portfolio, including Medicated Feed Additives, Nutritional Specialties, and Biologicals. This position involves managing new registrations and maintaining existing ones, working with local and international teams, as well as with regulatory suppliers applicable in Mexico and Central America.

Responsibilities:

  • Oversee, plan, prepare, and submit new applications, ensuring accuracy, completeness, and compliance with regulations and guidelines.
  • Label approval and coordination: Review, approve labeling, and coordinate with multi-disciplinary teams for their implementation.
  • Utilize databases to maintain current and complete documentation for animal health products.
  • Ensure regulatory compliance by preparing and directing audits for commercial and contract manufacturers operating in Mexico.
  • Monitor regulatory requirements and stay abreast of industry best practices in the animal health industry, assessing their impact on registrations and providing strategic guidance for ongoing compliance with regulatory requirements.
  • Develop and implement regulatory strategies for assigned projects.

Requirements:

  • Bachelor's degree, preferably in a scientific field or animal health, with 2 years of work experience in regulatory affairs for animal health.
  • Knowledge of regulatory requirements and guidelines for medicated feed additives and veterinary pharmaceuticals, nutritional, and biologics in Mexico and Central America.
  • English language: Full professional proficiency.


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