Senior Specialist, Regulatory Affairs (Animal Health)

Job description

Job Description Position Summary As a Regulatory Affairs Manager, the position is responsible for developing and executing regulatory strategies to ensure timely registration, lifecycle maintenance, and compliance of our company's Animal Health products in Malaysia and Singapore. The role serves as the primary liaison with regulatory authorities and collaborates with regional and global teams to support product approvals, market access, and business objectives. Key Responsibilities Manage regulatory submissions for new registrations, renewals, variations, and labeling changes. Ensure compliance with applicable regulatory requirements in Malaysia and Singapore and Brunei Darussalam. Act as the primary contact with regulatory authorities and industry associations. Provide regulatory support for product launches and lifecycle management activities. Monitor regulatory changes and assess their impact on the business. Collaborate with Commercial, Quality, Pharmacovigilance, Supply Chain, and Technical teams to ensure compliance and business continuity. Education Requirements Bachelor's Degree in Veterinary Medicine, Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, or a related scientific discipline. Registered Pharmacist or Veterinarian qualification is preferred. Advanced degree or certification in Regulatory Affairs is an advantage. Experience Requirement Minimum 3-5 years of Regulatory Affairs experience in the pharmaceutical, biotechnology, medical device, veterinary, or animal health industry. Experience managing regulatory submissions and approvals in Malaysia and/or Singapore. Strong knowledge of product registration, lifecycle management, and regulatory compliance requirements. Experience working in a multinational and cross-functional environment. Animal Health or Veterinary products experience preferred. Skills & Competencies Strong knowledge of regulatory requirements in Malaysia and Singapore. Regulatory strategy development and risk assessment. Excellent project management and organizational skills. Strong communication, stakeholder management, and influencing skills. Ability to manage multiple priorities and work independently. Proficiency in Microsoft Office applications and regulatory information systems. Fluent in English; proficiency in Bahasa Malaysia. Required Skills: Adaptability, Adaptability, Audits Compliance, Biotechnology, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Global Team Collaboration, Legal Compliance, Life Science, Manufacturing Compliance, Pharmaceutical Regulatory Affairs, Pharmaceutical Sciences, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Requirements, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Communications {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.