Manager, Regulatory Affairs - U.S. Animal Health

Manager, Regulatory Affairs - U.S. Animal Health

Location: Berkeley Heights, NJ or Columbus, OH

Job Type: Full Time

As a developer, manufacturer and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high‑quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high‑quality medicines accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Manager, Regulatory Affairs – U.S. Animal Health to join our team. In this role, you will lead regulatory strategy and execution for Hikma’s veterinary pharmaceutical portfolio, including injectables and oral solids. The role ensures compliance with applicable regulations, supports product development, registration and lifecycle management, and serves as liaison between the company and regulatory authorities.

The ideal candidate will bring deep animal health regulatory expertise, strong project leadership, and a collaborative mindset to drive successful regulatory outcomes. This role will start as an individual contributor with the aim of supporting the build‑out of the animal health function asional travel to regulatory meetings or manufacturing sites will be required.

• Develop and implement regulatory strategies for new and existing animal health pharmaceutical products
• Prepare and manage regulatory submissions (e.g., JINAD, NADA, ANADA, supplements) to FDA‑CVM authorities
• Oversee the maintenance and accuracy of technical regulatory information to ensure high‑quality, compliant submissions
• Ensure ongoing compliance throughout the product lifecycle
• Serve as animal health subject matter expert on cross‑functional project teams and connect with other Hikma global regulatory experts, providing animal health‑specific guidance from early development through lifecycle, offering strategic leadership and counsel across Clinical, Quality, and Business Development functions
• Provide regulatory insight by, in coordination with the Legal function, interpreting legislation and translating it into clear, actionable guidance to improve project outcomes and predictability
• Facilitate scientific advice and pre‑submission consultations
• Prepare and lead meetings with regulatory authorities
• Monitor emerging regulatory changes and assess impact on Hikma’s animal health portfolio
• Manage regulatory documentation and ensure accuracy and completeness
• Mentor other regulatory staff and contribute to team development
• Prepare risk assessments and regulatory evaluations for complex issues
• Maintain relationships with all regulatory bodies for animal health

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor’s or Master’s degree in life sciences, veterinary medicine, or related field.
• Minimum 5 years of regulatory affairs experience in the animal health pharmaceutical industry
• Strong knowledge of FDA‑CVM regulations and submission pathways
• Experience with pharmaceutical product development and lifecycle management
• Excellent communication, organizational, and project management skills
• Experience with clinical trial requirements is a plus

• Some experience with global regulatory submissions (e.g., EU, Canada)
• Familiarity with eCTD and electronic submission platforms
• Ability to interpret complex regulatory requirements and translate them into actionable strategies
• Fluent in English; additional languages are a plus for global roles

Base Salary: $120,000 to $180,000 annually.…