Primary Purpose of the Position:

• Lead and manage the critical regulatory tasks – i.e. registration strategy, dossier compilation, data and documentation review, submission execution, evaluation review etc.
• Demonstrate skills and knowledge in areas such as, but not limited to: strategy development, risk assessment and management; monitoring and communicating change in the regulatory environment as well as global communication; staff and vendor development and management.

Key Responsibilities:

New Product / Project Registration:

• Assessment: New projects evaluation and regulatory strategy development, work with other Global and local functions.
• Submission Plan: work with global team / local team for dossier preparation plan, including HK regulation requirements and timeline, identify any risk should be mitigated. Oversee the dossier preparation process to keep it on track. Compile, prepare and submit to the DoH. Negotiate and interact with DoH to ensure submission approval.
• During review: provide the strategy and solution to resolve any problem or concern from reviewer. Supervise team to prepare the response for the queries.
• Work with Global RA team, and Portfolio team to elaborate updated local requirements on submissions.

Post-approval Maintenance:

• Make the robust submission strategy for variation: make sure the compliance to HK regulation / requirements and ensure the supply continuity.
• Cooperate with manufacturing site and global CMC regulatory prepare the submission dossier.
• Accountable to communicate with all related stakeholders for any potential business impact caused by renewal and variation, including supply bidding, access etc. Work out implementation plan after approval.
• Coordinate and monitor artwork / packaging process.

Business Support:

• Provide regulatory support for commercial activities, e.g.: Tender submission support on registration information.
• Interpret regulatory impact on the company.
• Advise on information to be used for marketing promotional materials.
• Provide training for concerned colleagues on current and new regulatory requirements.
• Participate in professional associations, industry / trade groups.

Improve RA Department Work Processes:

• Review and ensure that processes are clearly defined in SOPs for all critical tasks / duties e.g. regulatory filings, artworks, etc.
• Training, proficiency, familiarity and application of SOP / WIs.
• Supervise RA staff member to maintain good record, databases, filing system of product registration and licenses.
• Monitor and maintain MA / license applications for all existing products.

Requirements:

• Basic Degree in Life Sciences specialties, e.g.: Pharmacy, Medicine, Biological Sciences
• 7+ years of regulatory experience in pharma and regulated industry
• Preferable at least 1 year in managerial role
• Flexibility to work in a cross-cultural diverse environment
• Basic knowledge in drug development, pharmacovigilance, QA would be advantageous
• A good balance of Regulatory and Business acumen
• Good knowledge of pharmaceutical & life sciences sectors and medico-ethics in such disciplines
• Solid knowledge and understanding of local drug / healthcare regulations and ability to apply them at work effectively