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Regulatory Affairs Manager (Animal Health)

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An exciting opportunity has arisen for a Regulatory Affairs Manager in the Animal Health sector. This role is based in Malaysia, within a top-ranked biopharmaceutical company. The successful candidate will be contributing to the company's presence in Malaysia and across Asia Pacific. This role offers the chance to manage and oversee all product’s regulatory lifecycle process; submission; approval and maintenance activities.

What you'll do:

As a Regulatory Affairs Manager in Animal Health, you will play a pivotal role in managing product registration and overseeing Regulatory Affairs activities within your region. You will be responsible for all aspects of a product's regulatory lifecycle process, from submission to approval and maintenance activities. Your role will involve interacting with national regulatory authorities, presenting new product submissions strategies, and maintaining our current product portfolio. You will also provide regulatory reviews of variation proposals, labelling, and additional submission documents. Collaborating with our global regulatory affairs functions, you will help develop strategies for global regulatory submission and approval. A key part of your role will be staying updated on legal and regulatory knowledge regarding the registration, importation, and sale of products.

  • Manage product registration and plan, manage, and oversee Regulatory Affairs activities within the coverage region.
  • Oversee all product’s regulatory lifecycle process; submission; approval and maintenance activities.
  • Interact with and present to national regulatory authorities on regulatory related new product submissions strategies and maintenance of current product portfolio.
  • Provide regulatory review of variation proposals, labelling, and additional submission documents.
  • Collaborate with global regulatory affairs functions to develop global regulatory submission and approval strategies.
  • Maintain up-to-date legal and regulatory knowledge on the registration, import, and sale of products.

What you bring:

The ideal candidate for this Regulatory Affairs Manager position brings a wealth of experience in the Animal Health industry. With a minimum of 5-7 years in Regulatory Affairs, you have a proven track record of handling the registration of veterinary biological products and dealing effectively with the Department of Veterinary Services (DVS). Your qualifications in Veterinary Science, Animal Science, BioMedical, Biochemistry, Pharmaceutical Science, or Biotechnology set you apart. Veterinarians or Pharmacists are also welcome to apply. Your strong interpersonal skills will be key in managing positive networking relationships.

  • Graduates with Science related degree eg. Veterinary science / Animal science BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
  • 5-7 years experience in Regulatory Affairs of Animal Health industries
  • Experience in handling registration of veterinary biological products
  • Ability to deal effectively with Department of Veterinary Services (DVS)
  • Veterinarian or Pharmacist qualifications are welcome
  • Strong interpersonal skills to manage positive networking relationships

What sets this company apart:

This is an opportunity to join a top-ranked biopharmaceutical company that has been recognised as one of the Best Employers in Singapore for two consecutive years. With over 60 years of presence in Asia Pacific, this company offers a chance to be part of a global Regulatory Affairs organisation. The company prides itself on its commitment to innovation and excellence, providing employees with opportunities for growth and development within a supportive and inclusive environment.

What's next:

Ready to take your career to the next level? Apply now!

Apply today by clicking on the link provided. We look forward to receiving your application!

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C

Contract Type: FULL_TIME

Specialism: Healthcare and Life Sciences

Focus: Regulatory Affairs and Quality Assurance

Industry: Pharmaceuticals

Salary: Market Aligned

Workplace Type: Hybrid

Experience Level: Mid Management

Location: Petaling Jaya

Job Reference: QCSYP3-D9FD9A7C

Date posted: 29 May 2024

Consultant: Victoria Gan

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