Job Description

Description

The Regulator Affairs Director will be responsible for providing leadership for Metropolitan Asia Cluster (including Southeast Asia, Taiwan/Hong Kong, and South Korea), ensure that all products to be released for sale in assigned markets comply with all appropriate statutory regulatory requirements, guidelines and all applicable internal Kenvue policy/procedures.

Collaborate with the market Leadership Teams, Regional Regulatory Affairs leadership teams and other key local, regional and global stakeholders in establishing short and long term regulatory strategy and direct the implementation to achieve business goals.

Responsibility of Regulatory Affairs Management

• This leader is responsible for the management of a Metro Asia regulatory organization and the delivery of successful regulatory strategies that support the business vision.

• Ensure regulatory requirements are understood and incorporated throughout the entire life cycle of the product. Support timely registration of products across the assigned markets.

• Maintain compliance with internal and external standards/regulations.

• Lead issues management across assigned markets portfolio in order to avoid business disruptions. Serves as a business enabler by responding effectively to issues and providing regulatory solutions as required.

• Manage the regulatory budget and related activities to contribute to the financial metrics.

Leadership / Team Management & Development

• Embrace and lead a culture of inclusiveness and multi-cultural engagement through coaching and feedback to team and the broader community.

• Attract, develop, and maintain a strong talent pipeline and team of diverse leaders. Enable a Kenvue behavior-based, high-performance culture within team

• Provide leadership, direction, coaching, and feedback to all Regulatory team members in Metro Asia cluster

• Benchmark capabilities, processes and tools against peer groups both internal and external

Policy shaping and External Engagement

• Monitor the regulatory environment in assigned markets to provide timely assessments to business leaders of any new/changing regulations.
• Provide consultation, interpretation and advice to relevant departments to ensure on-time compliance with regulatory guidelines/directives/national requirements.
• Drive competitive advantage with innovative and strategic regulatory solutions by shaping the policy.
• Cultivate and maintain working relationships with trade associations, government agents, and professional peers through various avenues. Actively lead and drive external engagement and policy shaping.

Tasks/Duties/Responsibilities

• Leads the regulatory affairs team in Metropolitan Asia Cluster and responsible for innovative regulatory strategy for short & long term. Works closely with internal and external partners to deliver the business commitment. Develops budgets and compliance related LCM management.
• Drives and implements talent strategies on hiring, developing, promotions, pay adjustments, performance appraisals, and other people-related decisions
• Monitor the regulatory and competitor environment and provide assessments of the impact of new and changing regulations/guidelines on the company\'s current products and pipeline. Ensure the company is represented and participates on appropriate industry body committees and working groups as required. Take the responsibility for shaping the regulatory policy and lead external engagement strategy.
• Works closely with commercial and cross functional leaders to ensure alignment and prioritization around innovation strategy, governance forum decision making, resources, and budgets et al.

Qualifications

• Job requires a University Degree in Pharmacy, Biology, Chemistry or related Life Sciences with 10 years technical experience and leadership role. An advanced degree is preferred in biochemistry, chemistry, pharmaceutical science, or equivalent
• Extensive RA leadership experience (10 years) at both operational and strategic levels partnering with senior business leaders -- ability to critically analyze and apply knowledge to develop innovative regulatory strategies. Possess a familiarity with the solid understanding of regulatory science, technology in pharmaceutical and FMCG industry, with strong business acumen.
• 10 years managerial experience with sizable team. Highly recognized people leader with excellent ethical and leadership skills. Has related team and change management capabilities/experience with the ability to integrate team into one cohesive group towards the same goal. Proven ability to lead, engage and inspire others.
• Seasoned regulatory professional with established Health Authority and Industry Association connections

Required Knowledge, Skills, and Abilities:

• Experience working in a pharmaceutical/consumer products company with a comprehensive understanding of the Regulatory Affairs
• Ability to strategically analyze, interpret and communicate technical/regulatory information with cross function team
• Good business acumen and understanding
• Exhibit an exceptional degree of ingenuity, creativity, and resourcefulness to apply and/or develop highly advance strategy and solution.
• Demonstrated leadership in leading and working in a cross functional team is required
• Multinational company experience desired - understanding western approaches and working well with glokbal and regional teams, whilst at the same time understanding the local markets practices to leverage.
• Excellent oral and written communication skills are required in order to interact with various levels of personnel within and outside the company in Metro Asia
• The ability to proactively sense and take action on problems and opportunities. The willingness to act quickly.
• The ability to lead and adapt change: Can effectively cope with change and acting as a leader in helping team to adapt to change
• The ability to shift gears comfortably; can decide and act without having the total picture; isn\'t upset when things are up in the air; can comfortably handle risk and uncertainty
• The ability and evidence of driving execution of strategies based on time and cost criteria
• The ability to deliver business results and solutions and keep the focus on driving impact. The willingness to assume personal ownership and accountability.
• The ability to make tough calls and take risks. The willingness to learn from experience and others.
• The ability to see possibilities and cultivate new ideas. The willingness to experiment and learn.
• The ability to motivate and empower others to achieve a desired action. The willingness to share talent.
• The ability to work well across functions and groups and to build effective teams. The willingness to put interests of enterprise above own

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