Title:  Manager, Regulatory Affairs - Animal Health

                                                                                                                                                                Manager, Regulatory Affairs – Animal Health (m/f/d)

                                                                                                                                                                                          Location: Zagreb

Hikma Pharmaceuticals purpose is to put better health, within reach, every day for millions of patients around the world. Through our global footprint of 30+ manufacturing plants, 9 R&D centres, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

We are looking for curious, motivated, and creative individuals who are excited to contribute to the development of high-quality injectable medicines. If you are passionate about science, eager to learn, and looking to launch or grow your career in pharmaceutical multifunctional teams, this is an opportunity to join our team and make a real impact.

In this role, you will be responsible for leading regulatory strategy and execution for Hikma’s veterinary pharmaceutical portfolio, which includes, but is not limited to, injectables and oral solids This role ensures compliance with applicable regulations and supports product development, registration, and lifecycle management, acting as a 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 out as an individual contributor role with the aim of supporting the build out of the animal health function at Hikma.  Occasional travel to regulatory meetings or manufacturing sites will be required. 

Key responsibilities:

• 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

What we expect:

• 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

Preferred Qualifications:

• 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

What we offer:

• Collaboration across teams and functions, building relationships with colleagues from different departments and regions
• A dynamic international work environment that values curiosity, growth, and innovation
• Permanent full-time position
• Competitive compensation package
• Annual health check-up and incident insurance policy
• Monthly food and travel allowances
• Free drinks, fruit and parking slot

If you are collaborative, like to innovate in the way you work, care about others, and are interested in a career where you can make a positive impact on people’s lives, apply no later than December 23rd, 2025.