Job Description

Contract type: FULL_TIME

Salary: Market Aligned

Location: Petaling Jaya FULL_TIME

Consultant: Victoria Gan

Job reference: QCSYP3-D9FD9A7C

Date posted: 25 January 2024 petaling-jaya healthcare-and-life-sciences/regulatory-affairs-and-quality-assurance 2024-01-25 2024-03-25 pharmaceuticals Petaling Jaya MY Robert Walters https://www.robertwalters.com.my https://www.robertwalters.com.my/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true

An exciting Regulatory Affairs Manager (Animal Health) job is now available at a global bio pharmaceutical company. The job will be permanently based in Malaysia to plan and monitor the registration time line setting and communication to the local and global cross-functional units.

About the Regulatory Affairs Manager (Animal Health) Role:
The Regulatory Affairs Manager (Animal Health) role is responsible for managing and overseeing all product\'s regulatory life cycle process; submission; approval and maintenance activities (variation, renewal) in relation to the national regulatory authorities of Malaysia, Singapore, and Brunei.

Key Responsibilities:

• Assess registration feasibility and acceptability of products for importation
• Identify data needed, prepare and/or obtain data and review to ensure that they are effectively presented for the registration of product
• Interact with and present to national regulatory authorities on regulatory related new product submissions strategies and maintenance of current product portfolio, as applicable
• 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
• Provide correspondence to national regulatory authority enquiry(s) for products responsible
• Provide regulatory advice and guidance to line management and cross-functional teams to ensure product submissions and importations meet regulatory requirements
• Review and verify packaging labels where applicable, revise labels by using PDF program per local regulatory authority requirement for registration and importation
• Develop SOPs and provide regulatory input to product lifecycle planning
• Manage secondary repackaging procedures in line with SOPs and regulatory requirements
• Maintain up-to-date legal and regulatory knowledge on the registration, import and sale of products
• Oversee and develop a team of highly motivated, experienced and dedicated direct reports

To succeed in the Regulatory Affairs Manager (Animal Health) job, you must have experience in handling registration of veterinary biological products. Experienced in dealing with Department of Veterinary Service in Malaysia (DVS), Singapore Animal and Veterinary Services (AVS), Brunei Division of Livestock and Veterinary Services.

Key Requirements:

• Graduates with a science-related degree (veterinary science/animal science bio medical, biochemistry, pharmaceutical science, biotechnology)
• Five to seven years of experience in regulatory affairs of animal health industries

This healthcare firm needs no introduction and is recognised as the leader in their field of expertise. The culture is demanding but if you are confident and have a can-do attitude the potential rewards are significant. The firm is also very focused on developing and training their people to the highest standards.

If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities await the right person in this exciting Regulatory Affairs Manager (Animal Health) job.

Apply today or email me directly at Victoria.gan@robertwalters.com.my to discuss this new opportunity.

Robert Walters