AP Regulatory Affairs Associate Director

AP Regulatory Affairs Associate Director

Title: AP Regulatory Affairs Associate Director
Location: Singapore-Singapore
AP Regulatory Affairs Associate Director
Janssen-Cilag Singapore
Global Regulatory Affairs - AP&LA Regulatory Affairs


About Us
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The AP Regional Affairs Associate Director 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 and head office-based "liaisons" to define and implement the regional strategy for assigned products


Responsibilities:
* Work with "head office-based liaisons" and local operating companies to define and implement the regional strategy for assigned products. Manages development and 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.
* Responsible for providing region or country 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.
* Supports product variations, including labeling changes, supplements, and amendments; Product License Renewals and providing regional affiliates with timely responses to Health Authority enquiries; as well as regulatory support to all affiliates in the region for the pharmaceutical sector business.
* Manage interactions with manufacturing sites as required to ensure the availability of proper standard export packaging components for product registration.
* Work with regulatory policy professionals as well as local affiliates to keep track of changes in country regulatory requirements and provide regulatory intelligence to head office.
* Will ensure adequate preparation for health authority meetings, and will need to attend and provide presentations to health authorities, where necessary.
Regulatory Strategy
* Expedites commercialization of new products, new indications and line extension via participation in the Regional Therapeutic Area 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. Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.
Health Authority and Operating Company Interactions
* Manages regulatory interactions with local operating companies and regional functions
* Serves as point of contact with local operating companies
* Interacts with local operating companies on individual products/processes
* Facilitates discussions with local operating companies on regional or global regulatory issues, as required
* Works with local operating companies to determine timing and strategy for regional HA meetings. Participate in preparations for interactions with HAs and assist operating company with these interactions.
* Acts as the primary contact with multifunctional regional teams such as regional marketing, Alliance logistics and supply chain and trademark office in US.
* Provides regulatory leadership on Regional Therapeutic Area Teams (R-TATs)
* Tracks regional post-approval commitments and ensures appropriate follow-up actions
* Tracks and updates tracking system of the major processes in the region
* Manages established products: variations, renewals, etc.
Submissions
* Provides input to submission tactical planning and timelines including submission during lifecycle (labeling changes, renewals and safety reports).
* Maintains generic content plans for submissions in the region, including clinical trials and registration submissions
* 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.
People Management
* May have people management responsibilities
* Provides coaching and guidance to local affiliates regulatory staff as appropriate
Additional Responsibilities
* Responsible for the management of regional in-licensed registration submissions, including drafting of the license agreement draft (regulatory aspect) 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
* Minimum of bachelor's degree, with pharmacy, life-science or health-related discipline preferred. Science/health-related degree if no prior pharmaceutical industry experience.
* Minimum of 8 years of relevant pharmaceutical industry experience, including at least 5 years of regulatory experience. Advanced degree candidates (MD/PhD/PharmD) with less regulatory affairs [3 years] and industry experience [5 years] will be considered.
* Regional or country regulatory experience required
* Hands' on experience in pharmaceutical product registration in an AP country, 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 leadership and contribution to drug development strategies.
* Demonstrated ability to handle multiple projects.
* Excellent verbal and written communication skills - proficiency in written and oral English is required
* Applicable language skills are preferred and may be required: familiarity with Mandarin, AP languages.
* 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.
* 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.

Regulatory Strategy
* 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.
* Broad understanding and experience of drug development and/or marketed products.
* Ability to stay abreast of regulatory developments in the region and assess business impact
* Awareness of pricing and reimbursement issues in AP&LA
* Understanding of how supply chain decisions impact registrations in AP & LA

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 regulatory strategy.
Labeling
* Knowledge of local labeling requirements.
* Ability to critically review labeling development/labeling revisions and assess impact on relevant countries
Resource Planning and Management
* Understanding of what is required to complete projects (resources, time, expertise, etc.)
* Mentoring & Line management skills
* Operates in a competitive, complex, and rapidly changing environment.
* Must make proposals and negotiate on prioritization and trade-offs on a project level.
* Provides input to department strategic objectives, goals and performance measures.
* Consults with supervisor on decisions regarding regional strategy in development plans and implementation tactics. Defines operational priorities and tactics. Resolves conflicts in priorities in consultation with supervisor, liaison team leader, business partners and internal customers.
* Presents issues and solutions to senior management in the region and Health Authorities Determines risk-management mitigation strategies for projects
* Makes informed decisions by soliciting input from others where needed.
* Makes complex decisions in situations with multiple, ambiguous objectives and constraints.

How to apply
Do you meet the requirements of this position and are interested in building a career with Johnson & Johnson? Go to , select the appropriate fields under "Search Jobs" and apply using requisition numberby 30 September 2011. All applications must come through the portal.