Regulatory Affairs Manager

1 day ago


กรงเทพมหานคร, Thailand Johnson & Johnson Full time

**Regulatory Affairs Manager**:
The manager, Regulatory Affairs Indochina is responsible for all aspects of regulatory responsibilities in Indochina. 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, re-registrations, copy clearance, global LCM labeling support, and external environment surveillance). The manager will be a member of both Thailand Surgical Vision Leadership Team and Thailand Vision Care Leadership Team. The manager will develop, actively mentor and supervise a team of regulatory professionals in Indochina. 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 across the region. This manager 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
- 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.
- 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.
- Anticipate emerging issues and develop solutions.
- Prepare and manage the budget (OOS/FTE) for department.

**Qualifications**:
**Required Knowledge, Skills and Abilities**:



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