MSD Associate Regulatory Affairs Manager AH 

Taiwan, Taipei 

528023772

Job Description

Job Overview

Under local regulatory requirements and responsible for all new product registration including new claims and licenses extension/renewal, to support business growth and business continuity, in compliance with local laws, regulations, guidelines and the company's policies & SOPs

Primary Accountabilities/Responsibilities

1. Under the general direction of supervisor, independently perform product registration including new product licensing and maintenance of existing product registration and renewals.

2. Compile registration dossier and prepare other regulatory documents (e.g., local package inserts, packaging components) and ensure timely regulatory submission under internal review and approval.

4. Support the progress of the registration projects by coordinating with the company’s internal departments (e.g. IRIS, Alexx, RTT, Reliance..etc)

5. Support the sampling process per commercial batches and work with Zuellig Pharma for tender operation.

6. Communicate and build relationship with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.

7. Input and properly maintain all regulatory and legal documentation.

8. Collect internal and external regulatory and competitive information and report to supervisor.

9. Establish and maintain general understanding and knowledge of regulatory requirements, regulatory SOPs and other functional systems.

10. Assist in Quality affairs projects and procedures that are related to regulatory affairs.

11. Assist in any other regulatory tasks as assigned.

12. Coordinate the execution of local development and/or post marketing studies when applied.

Qualifications, Skills & Knowledge

• Prefer bachelor degree in science or animal science.
• At least 3-5 years’ experience in Veterinary Medicine/Pharmaceutical Company regulatory affairs.
• Sound Knowledge of Taiwan regulatory processes and requirements.
• Good communication skills in English
• Excellent interpersonal skills to handle sensitive and confidential information/situations and able to network effectively across groups and levels.
• Able to work independently
• Able to work under pressure and compliance with deadlines.

Other Information

Able to travel to meet business commitments where required.

Current Contingent Workers apply

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