Regional Regulatory Affairs Manager

The **Regional Regulatory Manger Asia Pacific (AP)** is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with the local regulatory affairs departments, AP Compound teams, Global Regulatory Teams and head office-based team members (e.g. Regional Strategic Implementation Leader) to define and implement the regional strategy for assigned products. The position is accountable for leading and providing regulatory strategic input for assigned products.

The position, under the supervision, and supported by a supervisor, is responsible, for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements for successful regulatory filings for new products/indications within the oncology therapeutic area, including the opportunity for placement of clinical trials within the region.

The position also ensures (either directly or through staff) that product variations, including labeling changes, supplements, amendments, Product License Renewals are effected in the region. Furthermore, 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. This support includes J&J global products as well as licenced products (global, regional, local) and regional/local developed products.

Position will ensure that interactions with local/regional manufacturing sites are managed.
Position will also manage interactions with manufacturing sites as required to ensure the availability of propoer standard export packaging components for product registration.

Position will work with regulatory policy professionals as well as local affiliates to keep track of changes in country regulatory requirements and provide regulatory intelligence to regional management and head office. This support includes J&J global products as well as licenced products (global, regional, local) and regional/local developed products.

Position, under the supervision, and supported by a supervisor, will participate in the adequate preparation for health authority meetings, and may attend and provide presentations to health authorities, where necessary.

**Key Responsibilities**:
Provides direction for the activities related with assigned products. Works with regional management, head office-based team members ( e.g. Strategic Execution Leader )and local operating companies to define and implement the regional and local strategy for assigned products.

Under the supervision, and supported by a supervisor, is responsible for the development of the regional regulatory strategy and ensures the implementation of multi-national /regional regulatory and strategies that optimize development, registration, and lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

**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; supports the GRT by providing strategic regional input into compound development, registration and life cycle management.
- Expedites commercialization of new products, new indications and line extension via participation in the AP Compound teams to provide early regional regulatory inputs to identify barriers and needs to shape global developmental plan.
- 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

**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 wi