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Learn more at https://www.jnj.com/innovative-medicine

POSITION SUMMARY:

The Manager, APAC, Regulatory Affairs, Oncology 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, and 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, local) and regional/local developed products. 

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

The 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, local) and regional/local developed products. 

The 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. 

PRINCIPAL RESPONSIBILITIES FOR REGIONAL REGULATORY MANAGER, ASIA PACIFIC 

Provides direction for the activities related to 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 multinational/regional regulatory 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, and region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up to date on the 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 lifecycle management. 

• Expedites commercialization of new products, new indications and line extensions through participation in AP Compound teams, providing early regional regulatory input to identify barriers and needs and shape the global development plan. 

• Provides guidance to local affiliates on development of strategies to accelerate submissions and approvals. 

• Provides input in post-registration activities, including labeling changes. 

• Provides regional implementation and regulatory-based advice on new and updated Core Data Sheets. 

• Maintains expert knowledge of regional regulatory requirements and ensures that staff are 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 relationships with key stakeholders, including staff in the region and global R&D partners. 

• Interacts with local operating companies on individual products and 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 Health Authority meetings. Participates in preparations for interactions with Health Authorities and assists operating companies with these interactions. 

• Acts as the primary contact with multifunctional regional teams such as the Asia Pacific Therapeutic Area Strategic Team, regional marketing, Alliance logistics and supply chain, and the trademark office in the US. 

• Leads regulatory activities on AP Compound teams. 

Regulatory Submissions 

• Provides input to submission tactical planning and timelines, including lifecycle submissions such as labeling changes, renewals and safety reports. 

• Ensures maintenance of generic content plans for submissions in the region, including clinical trial and registration submissions. 

• Coordinates and follows up on post-approval submissions to ensure that products remain in compliance. 

• Reviews and provides input to critical submission documents. 

• Delivers 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 Health Authority questions. Provides clarification regarding Health Authority questions and input to the response strategy. 

• Ensures tracking of submission and approval milestones. 

• Ensures tracking of regional post-approval commitments and appropriate follow-up actions. 

Additional Responsibilities 

• Responsible for management of regional in-licensed registration submissions, including drafting the regulatory aspects of the license agreement draft, subject to review by the Regional Head. 

• Participates in 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 groups. 

• Provides support to the Head of Regulatory Affairs AP to develop metrics for the region. 

REQUIRED LEADERSHIP COMPETENCIES 

Credo - Demonstrate and inspire the behaviors that reinforce Our Johnson & Johnson Credo. 

Connect - Develop deep insights into the needs of our patients, customers, markets and communities. 

Shape - Drive innovation; anticipate and shape industry and market changes to advance health care globally. 

Lead - Create an environment where leadership and talent development is top priority. 

Deliver - Deliver results by inspiring and mobilizing people and teams. 

REQUIRED TECHNICAL COMPETENCIES & KNOWLEDGE 

Regulatory Strategy 

• Understanding of the pharmaceutical industry. 

• Knowledge of local laws, regulations and guidance in the region related to the full drug lifecycle. 

• Understanding of how laws, regulations and guidance apply to specific projects, and the ability to interpret them in the context of the scientific and commercial environment. 

• Understanding of and experience in drug development and/or marketed products. 

• Under the supervision and support of a supervisor, anticipates and influences regulatory developments in the region and assesses business impact. 

• Under the supervision and support of a supervisor, communicates AP regulatory strategy to global teams and assesses the impact on global/regional drug development. 

• Understanding of the scientific and medical principles applicable to the therapeutic area and specific products. 

• Awareness of pricing and reimbursement issues in AP. 

• Understanding of how supply chain decisions impact registrations in AP. 

Health Authority and Operating Company Interactions 

• Knowledge of Health Authority structures, how those agencies operate, and how and when to interact with them to generate a successful outcome. 

• Under the supervision and support of a supervisor, works with and influences Health Authority actions and outcomes. 

• Project-related knowledge of commercial and medical business needs. 

• Understanding of scientific data, including CMC, clinical and non-clinical data. 

Regulatory Input into Other Functions 

Comprehensive understanding of the needs of regional business partners. 

Submissions 

• Knowledge of laws, regulations and guidance as they apply to submissions in the region. 

• Knowledge of what is needed for dossier components and submissions, how to obtain regional components, and how long it will take to gather them. Understanding of documentation requirements. 

• Ability to analyze reports to determine whether they meet regulatory requirements and are consistent with the regional regulatory strategy. 

Labeling 

• Knowledge of local labeling requirements. 

• Under the supervision and support of a supervisor, critically reviews labeling development and revisions and assesses impact on relevant countries. 

• Knowledge of the competitive landscape and how other companies are dealing with similar labeling issues. 

• Under the supervision and support of a supervisor, undertakes labeling negotiations with health authorities. 

DECISION-MAKING AND PROBLEM-SOLVING 

Operates in a competitive, complex and rapidly changing environment. Must make proposals and negotiate prioritization and trade-offs at a project level. Has independence in decision-making regarding regional product strategies with supervisor approval. Defines operational priorities and tactics in the region. Resolves conflicts in priorities in consultation with the supervisor, regional business partners, head office-based team members (e.g., Strategic Execution Leader), and other internal customers. Determines risk-management strategies for projects. Makes informed decisions by soliciting input from others where needed. Makes complex decisions in situations with multiple, ambiguous objectives and constraints. 

Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards and regulations in drug regulation and personnel practices, but will not be explicitly circumscribed by these. 

INDEPENDENCE/AUTONOMY 

Operates independently in a complex environment. Independent in daily activities, with limited managerial oversight. Sets long-term work priorities for self in consultation with supervisor. The position makes determinations on routine work issues. 

REPORTING RELATIONSHIPS 

Reports to Director / Associate Director, Regulatory Affairs AP. 

RESPONSIBILITY FOR OTHERS 

Contributes to training of department staff members. May have oversight of work of other department members. 

WORKING RELATIONSHIPS/INTERFACES 

Internal: Within Regulatory Affairs 

• Regional Strategic Implementation Leader: to establish project objectives, support 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. 

KNOWLEDGE, EDUCATION, EXPERIENCE, AND COMMUNICATION SKILL REQUIREMENTS 

• Minimum of a bachelor's degree or equivalent in pharmacy, life science or a health-related discipline. Minimum of 8+ years of overall experience, including 5+ years of relevant pharmaceutical industry and regulatory experience; or Master's/PharmD and 6+ years; or PhD and 4+ years. 

• Hands-on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements, preferably with relevant experience in the oncology therapeutic area. Previous experience preparing documents for Health Authority submissions, including Clinical Trial Applications, Chemistry & Manufacturing documents, 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 Health Authority interactions. 

• Excellent verbal and written communication skills, with proficiency in written and oral English; Mandarin/Asian languages are preferred. 

• Ability to develop and maintain excellent working relationships and work successfully within a team environment and as an individual contributor. 

• Cultural sensitivity and ability to work and thrive in a multicultural environment, as well as an ability to work in a matrix environment. 

• 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 Microsoft Office programs and Internet resources. 

• Some regional business travel (10-15%) is required. Occasional international travel (3-5 times per year) may be required. 

• Ability to work flexible hours to accommodate early morning/evening meetings and teleconferences across different time zones. 

WORKING CONDITIONS/TRAVEL REQUIREMENTS 

The position is located in the AP region. The role requires flexibility to accommodate early morning or late evening meetings and teleconferences across different time zones. Regional business travel of 10-15% is required. Occasional international travel, approximately 3-5 times per year, may be required.

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