Description

Position Title : Regulatory Affairs Director, JJV Mainland China and Hong Kong
Location ：Beijing， China
Report to ： APAC Vision Head, Regulatory Affairs
Team size : 15

Position Summary
The Director Regulatory Affairs Mainland China & Hong Kong is responsible for all aspects of regulatory responsibilities in Mainland China, and Hong Kong. Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured, or distributed to meet all the required legislations in all applicable markets. Additionally, this role is responsible for directing post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, regional re-registrations, copy clearance, global LCM labeling support, and external environment surveillance). The Director will be a member of both the mainland China & Hong Kong Vision Leadership Team. The Director will develop, actively mentor, and supervise a team of regulatory professionals in mainland China & Hong Kong. This role has market & business level influence and responsibility and is considered a key opinion leader and an expert resource both within JJV and externally on all regulatory matters in mainland China & Hong Kong This Director will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information.

Major Duties & Responsibilities
1. Directs both growth/innovation and post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, renewals, copy clearance, global LCM labeling support, and external environment surveillance). Oversees the creation of global regulatory product development strategies and preparation/submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements. Ensure compliance with product post-marketing approval requirements. Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture.
2. Interacts with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business. Participate in applicable trade association/industry working groups to influence policy in alignment with business strategies.
3. Identifies and manages risks and business needs. Ensures the development and implementation of leading-edge systems and practices internally/across sites/companies. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
4. Sponsors departmental and cross-functional team development. Removes barriers. Provides project leadership or participates as a team member on major initiatives that have high impact to the business. Key member of leadership team. Applies influence across departments and the business.
5 Anticipate emerging issues and develop solutions.
6. Prepare and manage the budget (OOS/FTE) for department.

Required Qualifications
1. Bachelors Degree or above. 15+ years experience in relevant industry.
2. Expert knowledge, understanding, and application of principles, concepts, and practice of regional governmental regulations.
3. Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
4. Excellent organizational, communication, negotiation, and interpersonal skills.
5. Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.

Qualifications

Position Title : Regulatory Affairs Director, JJV Mainland China and Hong Kong
Location ：Beijing， China
Report to ： APAC Vision Head, Regulatory Affairs
Team size : 15

Position Summary
The Director Regulatory Affairs Mainland China & Hong Kong is responsible for all aspects of regulatory responsibilities in Mainland China, and Hong Kong. Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured, or distributed to meet all the required legislations in all applicable markets. Additionally, this role is responsible for directing post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, regional re-registrations, copy clearance, global LCM labeling support, and external environment surveillance). The Director will be a member of both the mainland China & Hong Kong Vision Leadership Team. The Director will develop, actively mentor, and supervise a team of regulatory professionals in mainland China & Hong Kong. This role has market & business level influence and responsibility and is considered a key opinion leader and an expert resource both within JJV and externally on all regulatory matters in mainland China & Hong Kong This Director will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information.

Major Duties & Responsibilities
1. Directs both growth/innovation and post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, renewals, copy clearance, global LCM labeling support, and external environment surveillance). Oversees the creation of global regulatory product development strategies and preparation/submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements. Ensure compliance with product post-marketing approval requirements. Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture.
2. Interacts with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business. Participate in applicable trade association/industry working groups to influence policy in alignment with business strategies.
3. Identifies and manages risks and business needs. Ensures the development and implementation of leading-edge systems and practices internally/across sites/companies. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
4. Sponsors departmental and cross-functional team development. Removes barriers. Provides project leadership or participates as a team member on major initiatives that have high impact to the business. Key member of leadership team. Applies influence across departments and the business.
5 Anticipate emerging issues and develop solutions.
6. Prepare and manage the budget (OOS/FTE) for department.

Required Qualifications
1. Bachelors Degree or above. 15+ years experience in relevant industry.
2. Expert knowledge, understanding, and application of principles, concepts, and practice of regional governmental regulations.
3. Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
4. Excellent organizational, communication, negotiation, and interpersonal skills.
5. Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.