[Innovative Medicine] Director, Regulatory Compliance (Asia Pacific)

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Learn more at J&J Regulatory Compliance (Asia Pacific)

Johnson & Johnson is the worlds 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 pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the worlds most pressing health issues. We are currently recruiting for Director J&J Regulatory Compliance (Asia Pacific) to be located in Japan.

DESCRIPTION

The Director J&J Regulatory Compliance (Asia Pacific) reports directly to the Senior Director J&J Regulatory Compliance (Asia Pacific).

Director J&J Regulatory Compliance (Asia Pacific) will be a member of the J&J Regulatory Compliance (Asia Pacific) team and a member of the Innovative Medicines Regulatory Compliance (IMRC) team within the JJRC organization. The J&J Regulatory Compliance Director (Asia Pacific) will be accountable for regulatory compliance of the Innovative Medicines Supply Chain sites in Asia Pacific. He/she will be responsible for compliance oversight and execution of key compliance programs to drive proactive and sustained compliance to enable compliant delivery of business objectives. The Director J&J Regulatory Compliance (Asia Pacific) will lead a team(s) of Compliance professionals to execute tactical compliance activities at the supply chain sites in the region.

RESPONSIBILITIES

• Serve as an expert regulatory compliance advisor and Subject Matter Expert on key strategic and critical compliance issues or activities for the Asia Pacific region.
• Understand site risk profiles and proactively identify and prioritize risks. Partner with stakeholders to escalate critical risks to the appropriate levels of management.
• Provide compliance expertise and regional compliance perspective in the development of risk mitigation strategies. Make decisions regarding the applicability of relevant Health Authorities regulatory requirements.
• Lead a team(s) of compliance professionals to provide compliance oversight and execute compliance programs to ensure compliance with all voluntary regulatory and statutory standards and requirements.
• Support successful product realization and advice businesses and Supply Chain on compliance strategies. Understands compliance risk profile proactively identify communicate and prioritize compliance risks. Partner with stakeholders to escalate critical risks to the appropriate levels of management and support the mitigation of compliance risk.
• Serve as a Subject Matter Expert to support proactive or reactive responses to issues including on-site support during regulatory agency inspections as well as review responses to regulatory agency inspections.
• Understand and communicate emerging external regulatory compliance issues and trends. actions.
• Partner with the stakeholders to identify prioritize and ensure implementation of new and revised regulatory requirements and expectations. Support implementation plans for regulatory requirement changes including routinely monitoring and verifying of implementation activities.
• Establish organizational talent strategy to include goals and objectives performance and development career and succession planning.
• Accountable for performance management personnel development and timely completion of 5 Conversations.
• Establish a high performance and continuous improvement culture driven by key performance metrics benchmarking and sharing of best practices.
• As applicable conduct and/or facilitate assessments e.g. pre-PAI audits Due Diligence audits Gap analysis to support business needs and assess compliance risk for the organization.
• Represents J&J Regulatory Compliance (Asia Pacific) in applicable Q&C and JJRC LT Forums and Councils.
• Provide regulatory compliance support to ad hoc committees and projects as necessary.

REQUIREMENTS

• Bachelors degree in science or related field is required.
• Graduate degree/studies in science engineering business organizational management or equivalent experience preferred.
• Minimum of 10 years of experience in Quality Assurance Operations and/or Regulatory Compliance is required.
• Experience in managing various aspects of Quality and Regulatory Compliance in an international / global regulated healthcare environment is required.
• Experience working in the Pharmaceutical Medical Device or Consumer regulated healthcare environment is required.
• Detailed knowledge of Pharmaceutical regulatory requirements is required. Knowledge of Asia Pacific regulatory requirements is an advantage.
• Experience working with the US FDA EMA and other foreign regulatory agencies is preferred.
• Demonstrated track record of achieving successful compliance outcomes remediating compliance issues and supporting regulatory agency inspections is required.
• Ability to build partnerships manage complexity and mediate issues is required
• Must have strong collaboration and influence management skills to partner effectively with Enterprise functions and across functions and ability to build consensus and impact outcomes without always having line authority is required.
• Proven track record of demonstrating collaboration across the organization and at all levels and leading direct or indirect teams to deliver results is required.
• Strong analytical and critical thinking skills and experience implementing risk-based oversight programs are required.
• Ability to balance technical understanding of products and processes with compliance perspective and business acumen is required.
• Strong communication and executive presentation skills are required.

LOCATION

This position will be based in Japan and may require up to 50% travel both domestically and internationally.

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