POSITION SUMMARY: Briefly state the objective of this position.
The Regional Regulatory Maanger 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, 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.
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 with these interactions.
- Acts as the primary contact with multifunctional regional teams such as Asia Pacific Therapeutic Area Strategic Team, regional marketing, Alliance logistics and supply chain and trademark office in US.
- Leads regulatory activities on AP Compound teams.
- Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
- Ensures maintainenance 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
- Responsible for the management of regional in-licensed registration submissions, including drafting of the license agreement draft (regulatory aspect) (Review by Regional Head).
- 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 AffaIirs AP to develop metrics for the region.
Additional Responsibilities pertaining to In Vitro Diagnostics (IVD):
- Helps to prepare and communicates with Janssen companion diagnostics colleagues (Regulatory, Commercial, and Program management), and with global regional representatives to provide information on IVD towards strategic product and IVD filing approaches for local filings. The medical devices may include IVD companion and complementary diagnostics.
- Participate in product meetings, reviews and provide input on regulatory impact. Creates and coordinates bridging requirements and timelines between Drug and IVD/medical device/software regulatory affairs and development teams. Responsible for participating in multidisciplinary teams of professionals located mainly in Asia Pacific region and the global GRA Oncology and Dx teams.
- Contributes to the development and realization of business, evaluating changes to developing regulations and approvals by local health authorities. Support world-wide registrations by collaborating to maintain appropriate external and internal contacts to obtain timely registration of Janssen products. Provide support in the region by collaborating with local Operating Companies to ensure timely evaluation of changes (regulatory impact assessment) from a global perspective. Provides updates regarding AP region applicable regulations, standards, and guidance.
- Especially in the AP region, be current and informed on new and pending approvals in companion diagnostic for specific therapeutic, and be knowledgeable of laws, directives, guidance(s) and requirements that can impact Janssen product development. Inform GRA management by providing assessments of the impact of new and changing regulations on the company objectives. Upload new or changed regulations, standards and guidelines in shared access locations such as SharePoint. Network with J&J regulatory colleagues across regions to assist with understanding the Johnson & Johnson global position(s). Assist with commenting efforts on new or revised regulations, as required
- Identify educational needs, assist with setting up training sessions and communication of sessions, and provide information on applicable regulatory topics to involved personnel across applicable legal entities.
- Co-ordinating cross-functional (eg Regulatory, Commercial, Market Access, etc) Companion Diagnostics interactions and platforms in the Asia Pacific 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 (Pharmaceutical):
- Understanding of the pharmaceutical industry
- 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.
- Understanding of and experience in drug development and/or marketed products.
- Under the supervision, and supported by a supervisor, anticipate and influence regulatory developments in the region and assess business impact
- Under the supervision, and supported by a supervisor, 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
Specific Knowledge in In Vitro Diagnostics (preferred):
- Good knowledge of Asian regulatorions and guidelines for In Vitro Diagnostics
- Familiar with development and validation of medical diagnostics including assays, instruments and software and companion diagnostics.
- Familiar with GCP and ISO 13485 Quality Management Systems.
- Good knowledge of and ability to navigate health authority web sites and information related to submission files (labels, health authority reviews, approvals) and requirements for Medical Devices and/or In Vitro Diagnostics (IVD knowledge preferred).
HA and Operating Company Interactions
- Knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome.
- Under the supervision, and supported by a supervisor, work with and influence HA actions and outcomes.
- Project-related knowledge of commercial/medical business needs.
- Understanding of scientific data (CMC, clinical and non-clinical)
Regulatory Input into Other Functions
Comprehensive understanding of the needs of regional business partners.
- 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.
- Knowledge of local labeling requirements.
- Under the supervision, and supported by a supervisor, 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.
- Under the supervision, and supported by a supervisor, undertake labeling negotiations with health authorities
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 project level.
- Independence on decision-making regarding regional 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., 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: Describe level of supervisory/managerial oversight.
- 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. . Position makes determination of routine work issues.
REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides.
- Reports to Director, Regulatory Affairs AP
RESPONSIBILITY FOR OTHERS (If applicable):
- May have oversight of work of other department members.
WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature.
- Internal: Within regulatory affairs:
- 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
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS: Describe the minimum knowledge, education, prior work experience, communication skill requirements for the position. Include any degrees, certifications, language, or computer skills which are required and/or desirable.
- Minimum of bachelor’s degree or equivalent in pharmacy, life-science, Technology or Engineering, or health-related discipline. Understanding of molecular biology would be helpful.
- Minimum of 8+ years of overall experience (5+ years relevant pharmaceutical industry and/or experience with in vitro diagnostics [eg companion diagnostics, medical devices] and regulatory experience) OR Masters/PharmD and 6+ years; PhD and 4+ years.
- Hands’ on experience in pharmaceutical product and/or in vitro diagnostics registration in AP countries and familiarity with AP regulatory systems and product registration requirements. Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and /or Registration dossiers)
- Demonstrated ability to handle multiple projects.
- Demostrated organizational skills
- Ability to communicate to senior level management.
- Working knowledge of Pharmaceutical and/or In Vitro Diagnostics regulations and guidelines in the region. General knowledge of regulations of drugs
- 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%) 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: Description of the anticipated working conditions and approximate travel requirements.
Position is located in any country in the region AP but no relocation sponsorship. Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones
Regional business travel (10-15%) is required. Occasional international travel (3-5 x/year) may be required.
Manager: Europe, US; Manager, Global Regulatory Affairs
New Zealand, Philippines, Malaysia, Thailand, Vietnam, Australia, Indonesia, India, China-Hong Kong S.A.R., China-Shanghai-Shanghai, China-Beijing-Beijing, Japan-Shinagawa-Tokyo, South Korea-Kangnam-ku-Seoul
Johnson & Johnson Pte. Ltd. (8435)