Manager, Regulatory Affairs, Apac

**Job Function**:
Regulatory Affairs Group

**Job Sub**Function**:
Regulatory Affairs

**Job Category**:
Professional

**All Job Posting Locations**:
Mongkok, Kowloon, Hong Kong, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Seoul, Korea, Republic of, Singapore, Singapore, Taipei City, Taiwan

Johnson & Johnson is seeking a Manager, Regulatory Affairs to join the Regulatory Affairs APAC team.

The Manager, Regulatory Affairs is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products.

The position, under mínimal supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration, and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.

**RESPONSIBILITIES**:
**Regulatory Strategy and Expertise**
- Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
- Participates as a standing member of the project related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
- Expedites commercialization of new indications and line extension by providing regional regulatory inputs to identify barriers and needs.
- Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals
- Provides input in post-registration activities, including labeling changes
- Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.
- Maintains expert knowledge in regional regulatory requirements and ensure that staff is expert in country and product-specific regulatory requirements
- Provides AP evaluation in licensing activities

**Health Authority, Operating Companies, and Business Partner Interactions**

Manages regulatory interactions with local operating companies and regional functions
- Serves as point of contact with local operating companies
- Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&D partners.
- Interacts with local operating companies on individual products/processes
- Facilitates discussions with local operating companies on regional or global regulatory issues, as required
- Provides guidance to local operating companies to determine timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assist operating company with these interactions.

**Regulatory Submissions**
- Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
- Ensures maintenance of generic content plans for submissions in the region, including clinical trials and registration submissions
- Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance
- Reviews and provides input to critical submission documents
- Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines
- Participates in “Rapid Response Teams” to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.
- Ensures tracking of submission and approval milestones
- Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions

**ADDITIONAL RESPONSIBILITIES**:

- Participates in the development of department processes and procedures. Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities and milestones
- Updates global regulatory staff regarding changes in regional regulatory requirements and provides support to VP, Regulatory Affairs AP as requested on initiatives.

**REQUIRED TECHNICAL COMPETENCIES AND KNOWLEDGE**:
**Regulatory Strategy**
- Good understanding of the pharmaceutical industry
- Detailed knowledge of local laws, regulations and guidance in the region related to full drug life cycle.
- Good understanding of and