Director Regulatory Affairs - Hematology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

China R-110634, Japan R-110635, Singapore R-108238

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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

POSITION SUMMARY:

The Regional Regulatory Leader 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 Integrated Value Teams, AP Therapeutic Area SLT and head office-based team members (e.g., C-ROSS Major Submissions) to define and implement the regional strategy for assigned products. The position is accountable for leading and providing regulatory strategic input for assigned TAs/products. 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 is responsible for consolidation of strategy and prioritization of AP countries, including Japan and China that are aligned with business and R&D objectives.

The position also ensures (either directly or through a partnership with C-ROSS Lifecycle Submission team) 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, 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. These activities would also include the support to regional and local implementation of strategies (e.g., generics, biosimilars, etc).

Position will oversee/ensure adequate preparation for health authority meetings, and will need to attend and provide presentations to health authorities, where necessary.

Directs Managers and/or senior individual contributors in a matrix environment, and is accountable for meaningful career development conversations and regular coaching and feedback.

Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.

Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

PRINCIPAL RESPONSIBILITIES for Regional Regulatory Leader – AP

Provides direction for the activities related with assigned TA/products. Works with regional management, head office-based team members (e.g., C-ROSS Major Submissions) and local operating companies to define and implement the regional and local strategy for assigned TA/products. Is accountable 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

• Ensures consolidation of strategy and prioritization of AP countries, including Japan, China, North Asia clusters, Australia/New Zealand, and India/Southeast Asia clusters, that are aligned with business and R&D objectives.
• 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.
• Makes sure the appropriate participation of AP RLs 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.
• Develops a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area.
• Expedites commercialization of new products, new indications and line extension via participation in the AP Integrated Value Teams, AP Therapeutic Area SLT 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
• Provides regional implementation and regulatory-based advice on new and updated Core Data Sheets.
• Maintains expert knowledge in regional regulatory requirements and ensures 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 (e.g., GRTs, CDTs).
• 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.
• Acts as the primary contact with multifunctional regional teams such as Asia Pacific Therapeutic Area SLT, regional marketing, Alliance logistics and supply chain and trademark office in US.
• Leads regulatory activities on AP Integrated Value Teams and AP Therapeutic Area SLT.

 Regulatory Submissions

• Is accountable for the development of the registration schedule for the region
• Advises the GRT, and as needed, CDT and R&D functional representatives, on required documents and processes to support HA contacts and submissions.
• Provides strategic input to CTA dossier content, scope and timing
• 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

People Management

• Leads people management/oversight for regulatory staff, including regulatory staff in LOCs
• Provides coaching and guidance to department and local affiliates regulatory staff as appropriate
• Participates in development and execution of a strategy to ensure development of talent; supports, mentors, and fosters talent development.

 Additional Responsibilities:

• Responsible for the management of regional in-licensed registration submissions, including drafting of the license agreement draft (regulatory aspect) (Review by Regional Head).
• Provides evaluation in licensing activities
• 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.

 Required Leadership Competencies: 

• Live Our Credo – Demonstrates and inspires the behaviors that reinforce Our Credo.
• Connect – Cultivates meaningful external relationships and partnerships outside of J&J, adding value and insights for the enterprise; insight-driven to proactively uncover critical unmet needs and turn them into new opportunities.
• Shape – Translates insights into innovative and viable products or solutions, creating value; challenges the status quo and leads change management activities, creating positive change; takes and properly manages risks, while maintaining the highest standards of quality and compliance, contributing to value creation
• Grow – Takes ownership for talent acquisition, performance and development in a way that enhances the performance and development of self and others; maximizes and leverages diverse perspectives, backgrounds and talent to generate innovative ideas or solutions to address organizational challenges; engages in and encourages others to have transparent and constructive conversations and encourages others, contributing to a high-performing organization. Empowers people to act with speed, agility, and accountability, enabling them to achieve organizational goals and strategies; makes decisions and takes actions based on a global and enterprise-wide mindset that adds value across the enterprise; balances short- and long-term strategic choices, positions the organization to achieve both short-term and expected future results

Required Technical Competencies & Knowledge

Regulatory Strategy

• Good understanding of the pharmaceutical industry
• Detailed knowledge of local laws, regulations and guidances in the region related to full drug life cycle.
• Understanding of how laws, regulations and guidances apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment.
• Good understanding of and 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 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

HA and Operating Company Interactions

• Detailed knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome.
• Ability to work with and influence HA actions and outcomes.
• Project-related knowledge of commercial/medical business needs.
• Good understanding of scientific data (CMC, clinical and non-clinical)

Regulatory Input into Other Functions

• Comprehensive understanding of the needs of regional and local business partners
• Good understanding of the global drug development environment

Submissions

• Detailed knowledge of laws, regulations, and guidances 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 it. 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.
• Ability to critically review labeling development/labeling revisions and assess impact on relevant countries
• Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling.
• Experience in labeling negotiations with health authorities.

Resource Planning and Management

• Understanding of resources, time, expertise, etc. required to complete projects
• Mentoring skills
• Line management skills

 DECISION-MAKING AND PROBLEM-SOLVING:

• Operates in a competitive, complex, and rapidly changing environment.
• Must make proposals and negotiate on prioritization and trade-offs on a TA/project level.
• Provides input to department strategic objectives, goals and performance measures.
• Independence on decision-making regarding regional TA or product strategies with supervisor approval.
• Defines operational priorities and tactics in the region. Resolves conflicts in priorities in consultation with supervisor, regional business partners, and head office-based team members (e.g., Regional Strategic Implementation Leader) and other internal customers.
• Presents issues and solutions to senior management in the region and Health Authorities.
• 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 very limited managerial oversight. Sets long-term work priorities for self in consultation with supervisor.
• Position makes determination of routine work issues.

 REPORTING RELATIONSHIPS:

Reports to VP, Regulatory Affairs AP 

RESPONSIBILITY FOR OTHERS

• Has direct line supervisory responsibility.
• May provide oversight for local operating company regulatory affairs staff.
• Contributes to training of department staff members.
• May have oversight of work of other department members.

WORKING RELATIONSHIPS/INTERFACES:

Internal:·      

• Within regulatory affairs:·      
• C-ROSS MS/LS: 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.
• Other functional areas: GRPI, Policy, CMC, etc.
• Interactions with Commercial, Medical Affairs, GCO, and Regional Teams as needed for projects 

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS: 

• Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline. Minimum of 10-12 years of overall experience (8+ years relevant pharmaceutical industry experience, including at least 5 years of regulatory experience) OR Masters/PharmD and 8+ years; PhD and 6+ years.
• Hands-on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements for innovative medicine. Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and/or Registration dossiers)
• Demonstrated leadership and contribution to drug development strategies.
• 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.
• Experience specifically in the region is a mandatory requirement
• Excellent verbal and written communication skills – proficiency in written and oral English; 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 (10-20%) is required. Occasional international travel (3-5 x/year) may be required.
• Must be able to work flexible hours to accommodate early morning/evening meetings/teleconferences with different time zones.

WORKING CONDITIONS/TRAVEL REQUIREMENTS:·      

• Position is located in the region AP. Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones
• Regional business travel (10-20%) is required. Occasional international travel (3-5 x/year) may be required.

COMPARABLE POSITIONS:

Director: Europe, US, LA; Director, Global Regulatory Affairs 

Required Skills:

Preferred Skills:

Business Writing, Collaboration, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking