Lead and manage a group focused on identifying regulatory and legislative trends and issues that have the potential to impact the development and marketing of J&J’s pharmaceutical products within the Asia-Pacific (AP) region with a special focus on China and provide high quality strategic input aimed at influencing the future healthcare environment. The GRPI AP Regional Lead partners with global and regional subject matter experts and groups including Local Operating Companies to engage in direct regulatory advocacy and influencing activities relating to regulatory healthcare policies. This is accomplished through a variety of activities, including participation in Trade Association initiatives, Health Authority meetings and consultation as well as contribution tocommenting on new legislation and guidances.
Principal Responsibilities
Regulatory Policy Global and Regional AP Expertise (30 to 40%)
Provide leadership for Proactive & Reactive Policy Development from the global and regional perspective
Provide Leadership For and Staff key regional Trade Associations and Professional Organizations
Provide expert advice on and interpretation of key regulatory policy issues affecting the global and regional environment
Regional AP Group Shared Roles & Responsibilities (30 to 40%)
Represent J&J in interactions with Health Authorities and Government Bodies on advocacy issues, fostering relationships with key decisions makers in policy and legislative areas.
Lead and develop effective approaches to global and regional regulatory policy activities, including generating of positions, influencing plans, tracking and internal communication.
Participate in defining and implement influencing strategies on key regulatory policy topics, partnering with subject matter experts, project teams, Government Affairs and Legal.
Develop effective approaches to and participate in Trade Association Committees and Initiatives, Professional Organizations activities and Health Authorities meetings and consultations.
Co-ordinate input into commenting on regulatory and legislative texts to help shape and influence key regulatory healthcare policies.
Provide feedback to all J&J pharmaceutical companies and relevant personnel on current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact or affect J&J businesses or products.
Support internal functions and/or groups through consultation and training on specific regulatory intelligence issues.
Represent J&J at key trade association and agency meetings and carry out tactical operations in the representation of J&J’s external regulatory policy strategy.
Ensure increased utilization of regulatory intelligence and policy across all businesses in the development of effective strategies and decision-making.
Regional AP Group Leadership (20 to 30%)
Provide leadership and management support to the Regional Group
Supervise and provide direction to the regional GRPI Staff
Lead activities of the Regional Group leveraging expertise to ensure optimal efficiency in meeting GRPI goals and objectives
Regulatory Knowledge Management Regional AP Expertise (10 to 20%)
Collaborate and partner with GRPI Intelligence & Knowledge Management to ensure effective and timely dissemination of Regional Regulatory Information, Intelligence and Knowledge
Drive the provision of global and regional expertise to the impact assessment of regulatory major development
Drive the provision of global and regional expertise to the response to regulatory intelligence consultation
SLT Membership (10 to 20%)
Collaborate and partner with other GRPI SLT members to ensure clarity of communication across GRPI and alignment when appropriate
Participate in GRPI SLT decision-making to ensure optimal efficiency in meeting GRPI goals and objectives
Decision-making And Problem-solving
Proactively identify issues and problems, have the ability to identify and assess risk and the chances of success and offer solutions and recommendations.
Make complex decisions that resolve regulatory or business issues and demonstrate acute understanding of the impact of decisions taken.
Interpret the applicability of regulatory legislation and processes to propose innovative solutions to regulatory challenges and areas of policy.
Ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key stakeholders.
Develop effective and highly communicative relationships across highly complex organizations of multifunctional personnel.
Exercise excellent judgment in assessing priorities and initiating projects, both with and without direction.
Display clear conception of approaches for external liaising and influencing with policy making vehicles.
Employ novel approaches to regulatory issues in response to a changing regulatory landscape, conveying and influencing key internal decision makers as to proposals.
Reporting Relationships
The GRPI Regional Lead reports to the GRPI department head based in the US.
Working Relationships/Interfaces
Internal
J&J Pharma Regulatory Affairs community, including GRA Senior Leadership Team and regulatory colleagues in J&J Pharma Operating Companies
J&J Pharma Trade Association leaders (e.g., RDPAC, APEC, PhRMA, BIO)
J&J Pharma R&D and commercial functional groups/disciplines, including GMS and local Operating Companies
J&J Pharma internal functional area experts and trade association leaders
Global GRPI team members, including policy SMEs
Global and regional policy action teams
Global Quality Assurance
Government Affairs & Policy
Legal
Global Regulatory Policy Council
J&J Consumer and Medical Device & Diagnostics regulatory and subject matter experts
Corporate Office of Science & Technology
External
Trade Associations (e.g., RDPAC, APEC, PhRMA, BIO)
Professional Organizations (e.g., Topra, CMR, DIA, RAPS, FDLI)
Health Authorities
Retional Government Bodies and Institutions
Key Opinion Leaders/Consultants
Education & Experience Requirements
A degree in law, pharmacy, medicine or science such as PharmD, MD or PhD.
Experience of regulatory authorities and their role in product approval and licensing.
Extensive experience in regulatory policy activities, gained within the region, national health authority, industry or trade associations.
Excellent working knowledge of the regional regulatory framework and how that applies to pharmaceutical and healthcare product development.
Highly developed network amongst regional regulators and other key associations and organizations.
Knowledge of regulatory texts, legal texts and extensive experience of regulatory affairs.
Related Experience
Minimum 12 years
Comparable Positions
Global Regulatory Policy & Intelligence, The Americas and EMEA Regional Regulatory Policy Group Lead
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