Job Responsibilities:

• Identifying and Implementing best practices in reaching Optimum efficiency in Filings & Resource Allocation to RA team. Define & Implement SOPs and Working Systems with local and overseas RA Teams.
• Track Progress & Performance of Back-office Teams to deliver on Tasks assigned.
• Be accountable for and Cause & Manage Timely Complete Drug Regulatory Submissions.
• Be accountable for the Maintenance and Upkeep of existing Drug Registrations through Product Lifecycle
• Coordinate and implement the registration process for the company products, with a view to continuously improvise and minimize deficiencies.
• Compilation and submission of Documents for Tender submissions to HA / DH Tenders.
• Strategy and Working Systems with Team and Full RA department locally and overseas.
• Work with our manufacturers to provide strategy and multiple options for meeting regulatory requirements
• Personally write and review regulatory submissions as needed.
• Organize electronic database (electronic library) of Regulatory Documents & offline Library.
• Consistently evaluate & optimise Registration process based on any deficiencies received.
• Successfully Negotiate with Regulatory authorities on behalf of Company objectives.

Requirements:

• Degree in Science
• minimum 5 years of regulatory working experience in MNC, Distributor in the pharmaceutical industry in Hong Kong
• Proven Strategy and Effectiveness to lead Teams Efficiently to FILE Dossiers and get Approvals in Hong Kong with minimum deficiencies.
• Experience of Filings with Drug Office, Department of Health, Hong Kong.
• Experience in negotiating with regulatory authorities, to expedite approvals.
• Experienced in TENDER Submission and Document Preparations.
• Existing network of connections in local industry and statutory bodies, an advantage.
• Excellent organizational and interpersonal skills, positive working attitude and be a good team player.
• Attend to details and able to work with limit supervision.
• Team Leader with proven Team management Capabilities
• Able to work with both internal and external customers from different level
• Fluent in English and Chinese, both written and spoken.

We offer attractive remuneration and fringe benefits. Interested parties, please send your full CV stating the position, your availability, current and expected salary via email to Apply Now

Chemill Pharma is part of a large Pharmaceutical Group having over 30 years of experience in the global pharmaceutical market. Established in 1999 in Hong Kong, we support generic drug companies, to produce and launch products successfully. We are now expanding our business to support the strategic growth of the business, we have exciting opportunities for talented, motivated and high caliber individuals to join us as one of our professional associates.