Manager, Regulatory Affairs - U.S. Animal Health at Hikma Pharmaceuticals PLC

Berkeley Heights, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

158000.0

Posted On

08 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Regulatory Execution, Veterinary Pharmaceuticals, Injectables, Oral Solids, FDA-CVM Regulations, JINAD, NADA, ANADA, Lifecycle Management, Project Leadership, Cross-functional Teamwork, Legislation Interpretation, Scientific Advice, Risk Assessment, Regulatory Documentation

Industry

Description

Location: Berkeley Heights, NJ or Columbus, OH Job Type: Full Time About Us: 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. Description: 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 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 Qualifications: 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 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 Compensation: Base Salary: $92,000 to $158,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Responsibilities

This role is responsible for leading the regulatory strategy and execution for Hikma’s veterinary pharmaceutical portfolio, ensuring compliance with applicable regulations across product development, registration, and lifecycle management. The manager will act as the animal health subject matter expert, providing strategic guidance across clinical, quality, and business development functions.