Regulatory Affairs Manager Animal Health Mnc

Petaling Jaya, Selangor, Malaysia

Job Description


In this role, the incumbent will play a pivotal role in providing essential support to the regulations of animal health products. Your responsibilities encompass overseeing regulatory submissions and adherence to government regulations within the country. Also, you will be responsible in formulating and conveying regulatory strategy and life cycle management details of all products while being the representative in engagements with external stakeholders.

  • Regulatory Insights and Strategy: Gather and relay regulatory trends and developments within the assigned region or country to head office, proactively anticipating potential shifts in the regulatory landscape. Engage actively in regulatory industry association working groups to predict and influence changes that impact new product approvals.
  • Regulatory Planning and Implementation: Devising, executing, and overseeing submission plans, aligning with both local and global requirements, to ensure timely and compliant product registrations for various products. Compile necessary local submissions, coordinating translations in accordance with local regulations.
  • Product Maintenance and Life-cycle Management: Execute tasks and submissions linked to Life-cycle Management (LCM) efforts within the designated area, providing essential backing for local portfolio optimisation and management.
  • Knowledge and Intelligence Oversight: Maintain thorough records of submissions and communications with health authorities, facilitating effective follow-up activities based on historical knowledge. Curate an archive for documents and electronic files, ensuring a comprehensive regulatory history that informs past and future activities.
Top 5 international animal health MNC with strong presence globally |Highly independent working environment with vast opportunities for growth
  • Study background: Bachelor\'s degree or professional qualification, preferably with major in Veterinary Medicine, Life Science, Pharmacy, or a related technical field.
  • Requires a minimum of 3 to 5 years of strong experience within the pharmaceutical/medical/animal health sector.
  • Strong regulatory and stakeholder management with NPRA and/or The Department of Veterinary Services (DVS)
  • Strong technical skills in project management, product development knowledge, regulatory strategy and recommend suitable solutions.
  • Must demonstrate strong Microsoft Office proficiency.
Our client stands as a prominent and dedicated player in the animal health industry, driven by a commitment to enhancing the well-being of animals across the country. Renowned for its innovative veterinary solutions, the company offers a comprehensive range of products and services catering to diverse species, from pets to livestock. With a global reputation for excellence, this company is trusted by veterinarians and animal owners alike, underpinned by cutting-edge research and technology. The company\'s core values emphasise compassion, expertise, and a strong sense of responsibility towards improving animal health and fostering healthier relationships between humans and animals.
  • Impactful Contribution: This company allows you to contribute to the well-being and care of animals. Your work will directly impact the health and quality of life of pets, livestock, and animals, making a positive difference in their lives.
  • Global Leader in Veterinary Solutions: This company is a recognised global leader in veterinary solutions. By being part of the team, you\'ll have the opportunity to work with cutting-edge products and technologies that are trusted by veterinarians worldwide.
  • Professional Growth and Learning: With access to a supportive work environment, training, and career advancement opportunities, you can expand your skills and expertise while building a fulfilling career.

Michael Page

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Job Detail

  • Job Id
    JD978945
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    72000 - 96000 per year
  • Employment Status
    Permanent
  • Job Location
    Petaling Jaya, Selangor, Malaysia
  • Education
    Not mentioned