Johnson & Johnson Careers
Regional Regulatory Affairs Manager, APAC
Requisition ID: 00001DOL
- The position is accountable 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, 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 licensed products (global, regional, and 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 proper 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 licensed products (global, regional, and 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.
- 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 via participation in the AP Compound teams to provide 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
- 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 (including CCDS changes) and milestones
- Updates HQ regulatory staff regarding changes in regional regulatory requirements and seeks to shape a favorable regulatory environment through networking with Industry Group(s).
- Provides support to VP, Regulatory Affairs AP to develop metrics for the region.
- Regional Strategic Implementation Leader: to establish project objectives, strategic execution and ensure knowledge sharing.
- Local Regulatory staff: as needed by project activities to develop and evaluate drug project strategies and objectives and ensure knowledge sharing to enhance product development and registration activities.
- Global Regulatory Leaders/Global Regulatory Teams: member of the Global Regulatory Team (GRT) with accountability for AP strategy ;
- Internal: Other functional areas:
- GRPI, Policy, CMC, etc.
- Interactions with Commercial, Medical Affairs, GCO, and Regional Teams as needed for projects
- Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline.
- Minimum of 8+ years of overall experience (5+ years relevant pharmaceutical industry and regulatory experience) OR Masters/PharmD and 6+ years; PhD and 4+ years
- Hands’ on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements. Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and /or Registration dossiers)
- Demonstrated ability to handle multiple projects.
- Demonstrated organizational skills
- Ability to communicate to senior level management.
- Working knowledge of regulations in the region
- Experience in HAs interactions.
- Excellent verbal and written communication skills – proficiency in written and oral English and [Mandarin/Asian (Asia) languages is preferred.]
- Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
- Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required
- Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
- Proficient use of technology including MS office programs and Internet resources.
- Some regional business travel (10 - 15%) may be required. Occasional international travel may be required.
- Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones.
Candidate can continue to be based in home country.
Please note that there is no relocation assistance provision for this position. The selected candidate can continue to be based in his or her home country.
Asia Pacific-China, Asia Pacific-Malaysia, Asia Pacific-Japan, Asia Pacific-Australia, Asia Pacific-China-Hong Kong S.A.R.
Johnson & Johnson Pte. Ltd. (8435)