MSD Regulatory Affairs Manager 

Taiwan, Taipei 

147238158

Job Description

Summary of Position

• Lead Regulatory Affairs team of our company's Animal Health Taiwan and Hong Kong to be responsible for all products (e.g. but not limited to, biological, pharmaceutical and devices) registration and market authorizations maintenance to be compliance to the related regulations. Strong relations with the various administrative authorities and stakeholders within the framework of the company's development strategy and in line with veterinary biological, pharmaceutical and devices regulations.
• Manage PV, internal compliance, and policies to ensure business operation is compliant with the company’s policies.

Major Activities and Responsibilities

Product Registration:

Lead the RA team to prepare and manage the annual product submission and approval plan by executing the corresponding work tasks force for existing market authorizations and upcoming new registrations. Involve in the country’s registration pipelines and strategically take all necessary actions or alternatives to accelerate the registration approval. Well communicate with company’s RA team (GRA) to ensure the product dossiers meet the local regulatory requirements. Maintain strong and good relationship and network with the different departments of authorities.

Local Regulation Monitoring & Compliance:

Lead the RA team to provide updates on legislation and regulations changes of Taiwan animal health/ veterinary products registration, importation, local quality inspection, testing. Timely communicate with GRA (regional, plant site and global) on changes in local requirements and propose solutions in compliance to new local regulations to ensure product supply. Engage with local or regional animal health associations and stakeholders to raise concerns and propose a compromised solution with authorities to minimize the regulatory hurdles for animal health industry. Ensure business operation is aligned with the relevant regulations.

Building Relationship with Official Bodies:

Manage internal PV, policies, and compliances.

Lead the RA team to ensure the PV management in line with the requirement of our company's AH. Ensure business operation is compliant with our company's AH’s policies and compliance requirement.

Background Requirements

Prefer bachelor diploma in science or veterinary medicine. At least 10 years’ experience in regulatory affairs in animal health industry. Have major experience in both of biological and pharmaceutical products of animal health. Fluent in Mandarin and English. Based in Taipei office. Hybrid work with 30% of travelling

Required Capabilities (Skills, Competencies)

• Solid knowledge of Taiwan regulatory processes and requirements.
• Good communication and negotiation skill.
• Strategic thinking and planning with agility.
• Strong business sense.
• Project management and problem-solving.
• People management
• Focused and strong network building skills.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.