Responsibilities :

Primary Function

•  Responsible for providing overall accountability for registration projects assigned & regulatory activities, in compliance with local applicable laws, regulations, guidelines, and company’s policies and SOPs. Besides performing routine registration activities for new products, Oversee and support potential manufacturing site change, Marketing Authorization transfer from legal regulatory owner to company and maintain licenses in the markets through renewals and product variations for all company products; the incumbent will assist in the development of regulatory affairs strategy and action plan as well as regulatory affairs activities assigned.

Primary Accountabilities/Responsibilities

•  Under the general direction of supervisor, independently perform product registration.
•  Compile registration dossier and prepare other regulatory documents (e.g., local package insert, packaging components) and ensure timely regulatory submission upon internal review and approval.
•  Provide technical expertise, local regulatory requirement understanding and sound scientific approach to global product development & R&D team.
•  Responsible for the progress of the registration project. Coordinate with company’s internal departments (e.g., Insight (Company Data Management System) in product registration process.
•  Communicate with regulatory agencies/institutes (name agencies) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
•  Work effectively and flexibly within and across the affiliate, regional, and global team to achieve overall Company regulatory deliverables.
•  AE/PC - timely /closely monitor complains/feedback from the field to ensure adverse events and product complaints reports submission as per company SOP and global/local regulatory requirements
•  Input and properly maintain all regulatory and legal documentation.
•  Collect internal and external regulatory and competitive information and report to the supervisor.
•  Knowledge of key laws, regulations and policies affecting company's business interests. Participates in meetings that drive affiliate’s strategy and outcomes.
•  Assist in development and review regulatory affairs SOP and other functional system.
• Assist in Quality affairs projects and procedures that are related to regulatory affair.
•  Assist in Market Access, Corporate & Government Affairs eg: Codex etc.
•  Coordinate the execution of local development and/or post-marketing studies when applied.
•  RAS, himself or herself to Adhere to company policies and procedures when interacting and promoting products to customers, to protect the company brand and business.

Qualifications:

•  Bachelor degree of Pharmaceutical Sciences
• At least 8 year experience in Veterinary Medicine/Pharmaceutical/Medical Devices regulatory affairs
• Solid knowledge of local functional skills.
•  Strong communication skills in English (both written and spoken).
•  Excellent interpersonal skills to handle sensitive and confidential information/situations and able to network effectively across groups and levels.
•  Good leadership and project management skills.
•  Good team player.
•  Demonstrates strategic thinking capability and ability to apply good judgment across diverse/complex issues.
• Ability to work under pressure and compliance with strict deadlines.
•  Ability to priorities or work with conflicting priorities.
• Advanced knowledge of MS Excel, Word, PowerPoint.