Manager, APAC, Regulatory Affairs, Immunology

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POSITION SUMMARY:

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.  

The position, under minimal supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration, and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

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.

RESPONSIBILITIES: 

Regulatory Strategy and Expertise

• Drives the development and implementation of the regional regulatory strategy that optimize development, registration, and lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards. 
• 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 if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
• Expedites commercialization of new indications and line extension by providing regional regulatory inputs to identify barriers and needs. 
• 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.

Regulatory Submissions

• 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

ADDITIONAL RESPONSIBILITIES:

• 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 and milestones 
• Updates global regulatory staff regarding changes in regional regulatory requirements and provides support to VP, Regulatory Affairs AP as requested on initiatives.

REQUIRED TECHNICAL COMPETENCIES AND KNOWLEDGE:

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.
• Under minimal 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 minimal 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 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.  Position makes determination of routine work issues. 

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:

• Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline.
• 5-10 years of overall experience in relevant pharmaceutical industry and preferably with regulatory experience. Regional experience preferred.
• Hands on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred.  Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and /or Registration dossiers) also preferred.
• 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 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.
• Minimal regional business travel (1 or 2 times per year) may be 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.

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