Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

The Opportunity 

Dechra is an international specialist veterinary pharmaceutical and biological products business. Our expertise is in the development, manufacture, sales, and marketing of high-quality products exclusively for veterinarians worldwide. The Regulatory Affairs (RA) group is responsible for contributing to the innovation, portfolio growth & transformation; for maintaining compliance of the business activities and/or site operations that require government approvals based on local and international animal health regulations, company values, global policies, quality standards and goals; as well as, for the maintenance of the establishment and products within the local and international regulation framework.

The Senior Manager leads the Mexico RA Team and is accountable for ensuring the ethical conduct of regulatory activities in strict adherence with relevant local and international regulations, laws and standards also based on company’s policies. Ensuring that products are in compliance with external regulations and internal standards. Establishing regulatory strategies, procedures, and regulatory controls for new products and/or business activities and/or site operations that require government approvals. The Mexico RA Team prepares and submits regulatory applications, such as permits, licenses, certificates and authorizations mandated by government agencies. Submits product notifications, approval requests, and quality testing results to applicable government and regulatory bodies. Executes audit processes to confirm compliance with applicable regulations and internal standards. Coordinates government interactions and compliance activities; interacts with regulatory agencies. Adheres to a controlled documentation system, ensuring meticulous record keeping and information services system, including electronic record retention processes in accordance with the provisions of the regulatory provisions.

The Senior Manager is accountable for meeting team goals as well as to mentor and develop individuals within the Team.

The Senior Manager will work closely with the country Commercial Leader to ensure that the regulatory strategies are aligned with the business needs and vision. Additionally, the Senior Manager will participate in industry groups relevant to the RA function.

The Senior Manager develops and maintains strong relationships within the broader Dechra regulatory team and cross-functionally.

Role Responsibility

• Lead the Mexico Regulatory Affairs Team
• Deliver regulatory strategies and timelines aligned with business needs
• Oversight and accountability of activities for maintenance of product and product licenses
• Oversight of registrations and maintenance of establishment and product licenses for defined Central American countries
• Regulatory review of advertising material
• Contribute to the management of the quality system for regulatory procedures
• Represent Dechra with the local regulatory agencies and relevant industry groups

The Ideal Candidate

• Over 6 years of experience in Regulatory Affairs, specifically within the Animal Health sector in Mexico
• Strong knowledge of Mexican regulatory requirements
• Previous team management experience
• Advanced proficiency in written and spoken English
• Proficient in computer skills, including MS Office (Excel, etc.)
• Excellent interpersonal and communication skills, both oral and written
• Proven ability to collaborate cross-functionally in a multicultural/international, matrix environment.
• Demonstrated networking, influencing and negotiating abilities; able to build trust and strong relationships with internal and external stakeholders.
• Ability and willingness to travel nationally / internationally ~20%.

Dechra Pharmaceuticals PLC