Regulatory Affairs Manager

Found in: beBee S MY - 2 weeks ago


Malaysia Michael Page Full time

About Our Client

Our client stands as a prominent veterinary pharmaceutical company in Malaysia, this organisation is dedicated to enhancing animal health through its extensive portfolio of vaccines and pharmaceuticals. With a strong commitment to innovation and collaboration, the company serves as a trusted partner for veterinarians and animal owners. Operating with a focus on research and development, it plays a vital role in advancing the well-being of animals in the region.

Job Description

  • Evaluate the feasibility and acceptability of product registrations for importation.
  • Set registration timelines, communicate effectively with the Regulatory Affairs (RA) team, and coordinate with local and global cross-functional units.
  • Identify and prepare necessary data for product registration, ensuring effective presentation.
  • Engage with national regulatory authorities, presenting strategies for new product submissions and maintaining the current product portfolio.
  • Conduct regulatory reviews of variation proposals, labelling, and additional submission documents.
  • Collaborate with global regulatory affairs functions to formulate global submission and approval strategies.
  • Respond to national regulatory authority inquiries for responsible products.
  • Review and revise packaging labels using PDF programs in line with local regulatory authority requirements.
  • Stay updated on legal and regulatory aspects related to product registration, importation, and sales.
  • Lead and develop a team of dedicated direct reports.

The Successful Applicant

  • Study background: Bachelor's degree or professional qualification, preferably with major in Veterinary Medicine, Life Science, Pharmacy, or a related technical field.
  • Certified / licensed pharmacist or Veterinarian would be an advantage.
  • Requires a minimum of 5 years of strong experience within the animal health sector with specialisation in regulatory affairs.
  • 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.

What's on Offer

  • 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: The company values your growth and development. With access to a supportive work environment, training, and career advancement opportunities, you can expand your skills and expertise while building a fulfilling career in the animal health industry.
  • Quality-Driven Focus: The company places a strong emphasis on quality and efficacy. By joining the team, you'll be part of an organisation that prioritises delivering high-quality products and medical solutions to meet the needs.
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