Overview
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. Under minimal supervision, the role leads and provides regional input into the global regulatory strategy and identifies regional requirements to optimize registration and lifecycle management of marketed products, considering current and proposed changes in regulatory requirements and standards. The position provides regional affiliates with timely responses to Health Authority enquiries and general regulatory support to all affiliates in the region for the pharmaceutical sector business.
Responsibilities
- Regulatory Strategy and Expertise
- Understand regional and local requirements and advise 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. Keep up-to-date on regional regulatory environment.
- Participate as a standing member of the project-related GRT; provide strategic regional input into registration and lifecycle management.
- Expedite commercialization of new indications and line extensions by providing regional regulatory inputs to identify barriers and needs.
- Guide local affiliates on developing strategies to accelerate submissions/approvals.
- Provide input in post-registration activities, including labeling changes.
- Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.
- Maintain expert knowledge in regional regulatory requirements and ensure staff have country- and product-specific regulatory expertise.
- Provide AP evaluation in licensing activities.
- Health Authority, Operating Companies, and Business Partner Interactions
- Manage regulatory interactions with local operating companies and regional functions.
- Serve as point of contact with local operating companies and maintain excellent collaborative relationships with key stakeholders including regional staff and global R&D; partners.
- Interact with local operating companies on individual products/processes and facilitate discussions on regional or global regulatory issues as required.
- Provide guidance to local operating companies to determine timing and strategy for regional HA meetings and assist with preparations for interactions.
- Regulatory Submissions
- Provide input to submission planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
- Maintain generic content plans for submissions in the region, including clinical trials and registration submissions.
- Coordinate and follow up on post-approval submissions to ensure compliance.
- Review and provide input to critical submission documents.
- Deliver on business-critical regulatory submissions in line with development and post-marketing priorities and timelines.
- Participate in “Rapid Response Teams” to ensure timely responses to HA questions and contribute to strategy for responding to questions.
- Track submission and approval milestones and regional post-approval commitments and ensure follow-up actions.
- Additional Responsibilities
- Participate in developing department processes and procedures to track and communicate key regulatory product activities and milestones within the regional regulatory office.
- Update global regulatory staff on changes in regional regulatory requirements and support VP, Regulatory Affairs AP as requested on initiatives.
Required Technical Competencies and Knowledge
- Regulatory Strategy
- Good understanding of the pharmaceutical industry and detailed knowledge of local laws, regulations and guidance in the region related to the full drug life cycle.
- Ability to interpret laws and guidance in the context of scientific and commercial environments; experience in drug development and/or marketed products.
- Ability to anticipate and influence regulatory developments in the region and assess business impact.
- Ability to communicate AP regulatory strategy to global teams and assess global/regional impact.
- Understanding of scientific and medical principles applicable to the therapeutic area and products, awareness of pricing and reimbursement issues in AP, and understanding of supply chain impact on registrations.
- HA and Operating Company Interactions
- Detailed knowledge of Health Authority structures and how to interact to achieve successful outcomes; ability to influence HA actions and outcomes.
- Knowledge of regional business needs and broad understanding of scientific data (CMC, clinical and non-clinical).
- Submissions
- Knowledge of laws, regulations, and guidance as they apply to submissions in the region, dossier components, and documentation requirements.
- Ability to analyze reports for regulatory compliance and alignment with regional strategy.
- Labeling
- Knowledge of local labeling requirements; capable of reviewing labeling development and revisions under minimal supervision and negotiating labeling with health authorities.
- Decision Making and Problem-Solving
- Operate in a complex, changing environment; propose priorities and trade-offs; independence in regional product strategies with supervisor approval.
- Define regional priorities, resolve conflicts, determine risk-management strategies, and make informed decisions with input from others as needed.
- Independence/Autonomy
- Operate independently in a complex environment with limited managerial oversight; set long-term work priorities in consultation with supervisor.
- Knowledge, Education, Experience, Communication Skill Requirements
- Minimum bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline.
- 6-10 years of experience in the pharmaceutical industry with regulatory experience preferred.
- Hands-on experience in pharmaceutical product registration in AP countries; familiarity with AP regulatory systems and preparation of health authority submissions (Chemistry & Manufacturing and/or Registration dossiers) preferred.
- Demonstrated ability to manage multiple projects and strong organizational skills.
- Ability to communicate to senior management; working knowledge of regional regulations and HA interactions.
- Excellent verbal and written English; Mandarin/Asian languages preferred.
- Ability to work in a matrix, build relationships, and adapt in a changing regulatory workplace.
- Proficient in MS Office and internet resources; minimal regional travel (1-2 times per year) and occasional international travel may be required.
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📌 Manager, Regulatory Affairs, APAC
🏢 Johnson & Johnson Innovative Medicine
📍 City of Ryde