APAC Regulatory Policy Director

APAC Regulatory Policy Director

• Top medical device company
• Abundant product line in Asia

Location: Beijing

Overall responsibilities:

Serves as the RA leader monitoring the Asia-Pacific regulatory landscape for changing regulatory requirements and opportunities.

Responsibility

Key responsibilities include:

• Serves as primary APAC legislative and regulatory expert
• Serves as the principal RA leader shaping and implementing the extremely fast pace and changing regulatory platform in key region.
• Proactively monitors APAC activity through systematic review of regulatory requirements.
• Identifies, cultivates, and nurtures relationships with APAC necessary to proactively monitor regulatory changes and trends.
• Assesses changes in APAC regulatory policy and analyzes impact on RA and individual Business Units.
• Provides consistent and timely information to Sr. Director, Global Regulatory Intelligence on the dynamic global regulatory landscape.

Functional and Technical Competencies:

• Knowledge of China, Japan, India and other APAC regulatory requirements, processes, and organizations across the medical device field.
• Ability to articulate regulatory policies and their implications to multiple audiences (internal and external).
• Work effectively with internal/external corporate regulatory groups, and trade associations to efficiently monitor regional regulatory policy.
• Strategic thinking and ability to partner with key external stakeholders at senior levels.

Leadership Competencies:

• Connect - Must develop and maintain regional relationships with key stakeholders (trade associations) and internal partners (Regions and BUs).
• Shape - Must manage and shape internal responses to proposed Tier 2 policy changes.
• Lead - Effectively drives regional regulatory intelligence.
• Deliver - Ability to achieve results under demanding time constraints with expansive and changing priorities.

Requirement

• Master's degree or equivalent required.
• Minimum 10 years of progressive experience in regulatory policy, public policy, government relations, or regulatory affairs leadership within the medical devices or related (healthcare, pharmaceutical) industry.
• Strong political acumen.
• Demonstrated leadership skills; responsibility for influencing external industry peers in building consensus for regulatory policy.