I. Position Summary
Lead the development and improvement of the regulatory affairs capabilities in the Greater China region (i.e., China mainland, Taiwan & Hong Kong otherwise known as region) in accordance with embecta requirements. Centrally manage and oversee main regulatory activities in the region by ensuring that regulatory standards and requirements are adhered to for all products destined for sale in the market, regardless of source of supply.
II. Key Responsibilities
Responsible for assuring products are cleared to market in the various countries in the region, plus assure compliance with local regulations and laws.
Development of short and long term regulatory strategies with the Regulatory Leadership and Commercial Teams
Actively monitors regional market regulatory requirements, ensures communication of such regulatory requirements to the operating plants and continuously monitors the environment for regulatory changes
Provides support for manufacturing plants to ensure that regulatory changes are addressed timely and efficiently.
Product Registrations for the Region
Compliance with FDA, Australian, European or other local regulation as appropriate
Monitor and communicate to business and regulatory leaders changes or new regulations and standards development in the Region
Active contribution as the Region RA representative to key strategic decisions impacting the development of regulatory compliance policies, processes and procedures
Compliance with appropriate national regulations in the Region.
Influence Region’s regulations and standards development
Active participation in the Greater China ASR meetings to discuss recent developments and strategic plan for countries within Greater China.
Strengthen ties with Medical, Commercial, and Operational groups.
Active member of the Regulatory Leadership Team and active participation in development of functional policies, standards and strategy.
Provide interpretation of existing and emerging regulations and make recommendations for changes in quality systems, policies or procedures to a minimum standard set by RA Leadership.
Ensure that all facilities in the Region comply with the company’s regulatory requirements or relevant national requirements.
Establish and maintain divisional regulatory systems:
MDR
Registrations
Licensing
Label and promotional material approvals
Establish programs and policies for interface with all pertinent regulatory authorities in areas of:
Government submission
Regulatory letter responses
Provide training in key regulatory areas for the Region;
New regulations
Dealing with regulatory inspectors
Perform auditing of regulatory systems (as appropriate) for facilities in the Region.
Develop regional and in country Regulatory Affairs associates.
Build relationships between the company and any Government agency, which could affect the company’s products.
Translate regulatory strategy into guidelines for execution by site/region
Coordinate resources, capacity and systems requirements as necessary across region
Product modification/adaptation decision/promotional material, e.g., use of a local brand, packaging, etc.
Coordinate regulatory activities in the region
Perform any other tasks as assigned.
III. Education
Science Degree (Pharmacy/Biotechnology), Engineering Degree or equivalent
IV. Experiences
Minimum 8 years of experience in the following:
Regulatory Affairs Systems
Product licensing and registrations
VI. Required Knowledge and Skills
U.S. FDA Quality System Regulations & Good Manufacturing Practices
European Medical Device, IVD Directives
ISO13485 Quality Systems
Local regulations within the region
Teamwork
Listens effectively (actively listens)
Include the RA Team in communications and activities where they must interact and cooperate
Have regular conference calls to promote sharing and learning
Promote inter-country assistance to leverage experience within the region
Recognizes the interests and achievements of others
Influencing Others
Establish foundation of credibility based on integrity and past performance
Be attentive to the different ways that others are persuaded
Gain acceptance by understanding the viewpoints of others and seeking win/win solutions
Ability to build relationships and influence with regulatory peers in the global businesses, other regions, other functions, and with country and region leadership.
