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Singapore, SG

VICE PRESIDENT, REGULATORY AFFAIRS ASIA PACIFIC-00000A1V

Description

VICE PRESIDENT, REGULATORY AFFAIRS ASIA PACIFIC

Janssen

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.

Description

The Regional Head is a member of the Global Regulatory Affairs organization. The position resides in the assigned region (Asia Pacific) and is responsible for leading regulatory affairs activities at the regional level. The position is responsible for driving the long-term growth strategy and vision for regulatory affairs in the region, including influencing of Health Authorities through networking and and active participation in local and regional trade associations. The position provides leadership and guidance in aligning regulatory affairs in the region to ensure synergy and integration among countries within the region and globally, and ensuring strategic input into product-related activities (development and lifecycle).

The position is also responsible for the management of staff in the region - at a regional office and local operating company level. The Regional Head ensures that the region is optimally run to support the needs of operating companies and the global/regional regulatory functions such that products are expeditiously developed, submitted and approved within the region. The position ensures understanding and alignment of global, regional and local goals and objectives. The position is responsible for working with global compliance functions to ensure a solid and reliable compliance level at the regional and local levels.

As a key management position in the region, this position will have an important influence both in the region and in Global Regulatory Affairs. In the region and, in addition to representing Regulatory Affairs on the regional management board/team, the position contributes to key regional governance issues including business decisions, people management, product prioritization, etc. This individual is also a key member of the GRA Regional Regulatory Affairs management team, ensuring regional integration with global regulatory strategies and processes.

This position reports to Vice President, Head of Regional Regulatory Affairs and Global Regulatory Operations. And has a dual reporting relationship to Company Group Chairman, AP, with strong connection with R&D Head Asia Pacific.

RESPONSIBLITIES

Organization and Talent Development

Develop a premier regional Regulatory Affairs team, including Regulatory Affairs staff in the local operating companies of the region. Build and lead a regional regulatory affairs organization acoss the Janssen (J&J Pharma) organization covering all therapeutic areas and local operating company organizations. Represent Janssen (J&J Pharma) in Cross-Sector initiatives.

- Provide direction for the activities and operating processes of regulatory affairs in the region.
- Align goals and objectives with R&D companies and commercial operating companies; ensure harmonized approach for input into product development, compliance, training, career development, etc.
- Provide line management, supervision, and coaching of regulatory staff; Provide functional guidance and management to regulatory staff in local operating companies. Work with LOC staff to ensure appropriate staff allocation to functions outside of RA, such as HCC, Pricing, PV, and Quality Management.
- Lead Local Operating Companies
- Ensure Heads of LOCs are aligned with TA head strategy and oversee appropriate local execution with regard to Regulatory Agency interactions, including adherence to corporate image
- Interact with LOCs on individual products/processes as required
- Ensure that functional networks between global or regional groups operate optimally to ensure appropriate representation of local regulatory requirements and strategy at Regional and Global level
- Work with LOC supervisors to plan and execute objective setting, performance reviews, personal development, training, etc.
- Ensure development of staff, creating opportunities for regulatory staff outside of their LOC.

- Ensure that staff are knowledgeable about products, and are provided with appropriate technical/therapeutic area training
- Develop and execute a strategy to ensure development of talent and build a pipeline of future regulatory leaders; Support, mentor, and foster talent development.
- Develop and deploy metrics to benchmark performance.
- Ensure development and/or implementation of processes or procedural documentation to support compliance with global and corporate guidelines and policies for regulatory affairs, including identification of gaps and ensuring appropriate training.
- Work with local/regional management on logical cluster of countries to maximize efficiency of RA functions.
- Represent RA in regional management groups (APMS LT) and contribte to these management groups as a competent and skilled business leader.

Regulatory Strategy

Ensure an optimal regional regulatory strategy for the organization. Ensure alignment of regional regulatory strategy with global regulatory strategy. Ensure development and execution of optimal regional regulatory plans for products in the region. Ensure that regulatory affairs is adequately represented in business teams, creating regional value for the portfolio.

- Provide oversight and guidance on the development and implementation of multi-national/regional registration and compliance 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.
- Provide input to critical submission documents throughout the product lifecycle to ensure that they support the regional requirements.
- Ensure alignment of regional product strategies, including registration timelines, with global compound teams.
- Maintain expert knowledge in regional regulatory requirements and ensure that staff is expert in country and product-specific regulatory requirements.
- Provide guidance to staff in developing options to manage risks and overcome barriers.
- Provide input into decision making and processes that impact registration and commercialization of products in the region, for example, input into supply chain decisions, placement of clinical trials, etc.
- Lead regulatory participation in Regional teams (including AP TASTEs, and regional compound teams), and ensure staffing to provide appropriate input.
- Ensure that Health Authority engagement strategies are defined for proactive and reactive communications.

Health Authority and Key Stakeholder Interactions

- Ensure optimal relationships with key Regulatory Agency leaders; Ensure the appropriate influencing of the regulatory environment.
- Establish relationships with local Health Authorities and support regional regulatory staff in their relationship and interactions with HAs.
- Ensure that staff are provided with appropriate technical/therapeutic area support for HA interactions.
- Ensure excellent collaborative relationships with key stakeholders, including management staff in the region and R&D partners.
- Ensure representation in key industry trade associations.
- Participate in establishing regulatory policy priorities.

Resource Planning and Management; Operational and Compliance Excellence

- As a member of the Regional GRA regulatory management team, participate in setting strategic and operational direction for the regional regulatory affairs organization.
- Provide leadership for business planning activities and process development.
- Foster and maintain ongoing communication and alignment with key stakeholders and business partners
- Actively participate in other management and leadership forums
- Work with GRA compliance groups, as well as with regional compliance functions to implement processes, standards, and training that ensure a high level of regulatory compliance.
- Ensure that systems are in place and staff are trained to track MAH obligations, HA queries, CMC questions, CCDS changes, product approvals, submissions excellence, etc.

Qualifications


REQUIRED

Education and Experience

- Minimum of a bachelor's degree in science/health-related field. Advanced degree is a plus.
- Minimum of 15 years of relevant pharmaceutical industry experience (for example, in clinical research, regulatory affairs, or medical affairs); 6+ years in Regulatory Affairs preferred.
- Must possess a good understanding of R&D and commercial processes and business needs.
- Experience in a local operating company and/or regulatory agency is a plus.
- Working knowledge of regulations and guidelines related to drug development and registration. Breadth of global regulatory affairs experience in drug development and commercialization (for example, experience in multiple therapeutic areas, multiple phases of drug development, multiple countries).
- Global regulatory or drug development experience, with experience in contribution to drug development strategies
- Experience in Health Authority interactions. Ability to act as company spokesperson with Health Authorities.
- Experience specifically in the region is highly desirable, though relevant global experience will be considered.

Skills

- Demonstrated leadership, organizational, and people management skills. Track record of staff development. Able to develop highly motivated and talented people.
- Excellent English verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a multi-discipline matrixed environment are required.
- Excellent interpersonal skills; adept at building relationships at all levels of an organization.
- In-depth cultural awareness and understanding of business etiquette.
- Facilitation skills to generate consensus among key customers and stakeholders. Strong influencing skills.
- Delivery of results and experience accomplishing objectives through people
- Ability to influence senior level management
- Demonstrated ability to multi-task, handle multiple complex priorities. Forward thinking. Ability to manage crisis situations.
- Demonstration of long-term strategic insight and innovative thinking.

Technical Competencies

Regulatory Strategy

- General knowledge of regional and 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 drug development and lifecycle management activities.
- Broad understanding of the global pharmaceutical business and the region, including the regulatory environment, commercial strategy, clinical development, and competitive dynamics.
- Ability to stay abreast of regulatory developments in the region and assess business impact.
- Basic understanding of the scientific and medical principles applicable to medicinal products.
- Knowledge of the competitive pharmaceutical landscape
- Ability to evaluate submission content in view of product regulatory strategy, HA requirements, and commercial needs.
- Knowledge of global and local labeling requirements.

HA and Key Stakeholder Interactions

- Ability to guide others in engagement strategies with Health Authorities.
- Ability to communicate and interpret HA processes and practices to business partners and subordinates.
- Experience in conflict resolution between the company and 3rd parties (HAs, licensing partners, etc.)
- Knowledge of regional commercial business and operating company needs.
- Comprehensive understanding of the needs of regional business partners.

Resource Planning and Management

- Able to apply project management principles to ensure smooth department operations (identification of human resource requirements and expertise, budget management, time, etc.)
- Managerial (line management) and coaching/mentoring skills.

Knowledge

- In-depth knowledge of the regulatory environment, guidelines and practice of assigned regions
- Knowledge and understanding of the pharmaceutical business, health care environment and regional emerging market social economic dynamics
- Understanding of the global regulatory and health care environment
- Multi-lingual (excellent English required plus applicable language(s) of the region, i.e., Mandarin, etc).

Others

- Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones
- Must be able to travel internationally and regionally - frequent travel within the region (approx 15-20%) is required, with occasional intercontinental travel.

LOCATION

This position is to be based in the APAC region. The role holder will be expected to be based in their current country of residence, within Asia-Pacific.

No relocation support will be provided.

APPLICATION DEADLINE

13 February 2013

Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Other Locations:Asia Pacific-China-Hong Kong S.A.R., Asia Pacific-Malaysia, Asia Pacific-Philippines, Asia Pacific-Australia, Asia Pacific-South Korea, Asia Pacific-China, Asia Pacific-Thailand, Asia Pacific-Indonesia, Asia Pacific-Japan, Asia Pacific-Vietnam
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Regulatory Affairs