Regulatory Affairs Associate

About Us:
VetPlus Limited is the global leader in the manufacture and supply of veterinary nutraceuticals. With five international subsidiaries in Germany, Spain, Portugal, Ireland, and the USA, and 52 exclusive partners worldwide, we are committed to expanding our regulatory presence on each continent to meet the growing demand for product regulation.

Role Overview:
We are seeking a Regulatory Affairs Associate (RAA) for the LATAM region to assist with maintaining regulatory compliance and product registration. This role involves providing regulatory knowledge on ingredient and product changes, coordinating regulatory documentation, and supporting product changes and registration within the LATAM region.

Key Responsibilities:

Regulatory Administration

• Support the preparation of export/import documents (e.g., Certificate of Analysis, Export Health Certificate) by advising on accurate requirements for countries in the region.
• Maintain tracking systems for registration changes and all relevant stages of registration and licensing.
• Provide regular project updates to the Head of Regulatory Affairs.

Artworks and Promotional Materials

• Review product labels, literature, and packaging to ensure compliance with local legislation and provide feedback to stakeholders.
• Assist in reviewing promotional materials according to relevant regulations.

Marketing Authorisations and Product Registrations

• Assist with compiling, translating, formatting, and adapting regulatory documents for new product registrations.
• Track and assist with product renewals/extensions and variations for existing Marketing Authorisations.
• Produce standard regulatory dossiers valid for multiple countries in the region.
• Act as the Deputy of Regulatory Affairs Executive, LATAM, providing regulatory support to distributors during RAE-LATAM’s absence.
• Provide feedback on requirements for registering or marketing products, including interpreting regulations.

Regulatory Intelligence

• Work with distributors and national authorities to clarify registration requirements and understand product registrations.
• Communicate regulatory news impacting ingredients and products, suggesting necessary actions.

Occasional Duties

• Attend staff meetings and training as required.
• Travel to other sites and meet with governing bodies and National Authorities as needed.
• Participate in telephone conferences outside normal office hours due to the UK-based Head Office.

Personal Attributes:

• Bachelor of Science degree (Or Veterinarian: Chemist or Pharmacist or equivalent)
• Fluent in English; bilingual in English and either Spanish or Portuguese.
• 2+ years’ experience in Regulatory Affairs, ideally in Veterinary Medicine or Animal Feed Regulations in Latin American markets.
• Experience working with regulatory bodies on product registration.
• Strong interpersonal and communication skills.

Skills and Competencies:

• Proven project planning skills.
• Strong written and verbal communication skills.
• Highly developed interpersonal and team skills.
• Ability to work under pressure and handle multiple complex tasks.
• Strategic thinking with the ability to work independently to meet deadlines.
• Adaptability to change and new circumstances.
• Experience dealing with external customers.
• Excellent time management skills.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Expectations:

• Act with honesty and integrity at all times.
• Demonstrate high standards of personal conduct.
• Value and respect colleagues and other staff members.
• Collaborate to develop and improve services.
• Take personal responsibility for words, actions, and service quality.