Sr. Specialist, Regulatory Affairs

Job Description

Responsibilities:

• Collaborate closely with global colleagues to prepare dossiers for veterinary medicine product registration in China (e.g. variations renewals GMO applications) providing guidance on Chinese regulatory requirements and conducting regulatory assessments.
• Support regulatory affairs operations including but not limited to artwork management and pharmacovigilance to ensure compliance with regulations and company policies.
• Communicate effectively with authority and internal stakeholders to ensure product registrations in China meet all requirements and deadlines.
• Maintain regular contact with Chinese authorities and agencies such as MARA IVDC and China Customs to monitor registration progress; coordinate with global colleagues to respond to questions as needed.
• Interface and collaborate with the companys distributors and importation agencies to prepare and provide necessary documentation for sample importation and product marketing.
• Assist the supervisor in problem solving and related tasks.

Requirements:

• MS degree or higher with preventive veterinary medicine veterinary medicine clinical veterinary pharmaceutical biopharmaceutical related fields.
• Minimum of 3 years direct regulatory affairs experience in veterinary or human health products R&D QA BTS or related areas.
• Demonstrate ability in problem-solving and agility to drive excellence.
• Good oral and written communication skills in both English and Chinese.

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