Job Description

The Associate Director, Regulatory Affairs, APAC 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 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 will ensure adequate preparation for health authority meetings, and will need to attend and provide presentations to health authorities, where necessary.

RESPONSIBILITIES:

Provides direction for the activities related with assigned products. Works with regional management, head office-based team members (e.g. Strategic Implementation Leader) and local operating companies to define and implement the regional and local strategy for assigned 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

• 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
• 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.
• 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.

Regulatory Submissions

• 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

People Management

• May include people management/oversight responsibilities for regulatory staff
• Provides coaching and guidance to department and local affiliates regulatory staff as appropriate
• Participates in development 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).
• 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.

• Minimum of bachelor\'s degree or equivalent in pharmacy or life-science or health-related discipline.
• Minimum of 8-10 years of overall experience (7 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 (Clinical Trial Application, Chemistry & Manufacturing, and /or Registration dossiers)
• Previous experience working on gene therapy products is desirable
• Demonstrated leadership and contribution to drug development strategies. (Associate Director)
• 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
• 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 may be required.
• Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones.

Regulatory Strategy

• Good understanding of the pharmaceutical industry
• Detailed knowledge of local laws, regulations and guidance in the region related to full drug life cycle.
• Understanding of how laws, regulations and guidance 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.
• Broad understanding of scientific data (CMC, clinical and non-clinical)
• Regulatory Input into Other Functions
• Comprehensive understanding of the needs of regional business partners.

Submissions

• Detailed 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 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

eQuest