ASPAC Regulatory Policy Director,leading medical device company
|Job Title:||ASPAC Regulatory Policy Director,leading medical device company|
|Contact Name:||Cherry Zhu|
|Job Published:||September 07, 2017 10:04|
Our client, one leading medical device company is seeking a ASPAC Regulatory Policy Head role, Profile Search & Selection is acting as the Employment agency in relation to this vacancy.
Job Title: MD ASPAC Regulatory Policy Head (Director level)
Department: MD, RA, Regulatory Policy
Reports To: Sr Director, Global Regulatory Intelligence
Serves as the MD RA leader monitoring the Asia-Pacific regulatory landscape for changing regulatory requirements and opportunities. Communicates dynamic regulatory information into Sr. Director, MD Global Regulatory Intelligence.
POSITION DUTIES & RESPONSIBILITIES:
Key responsibilities include:
- Serves as primary ASPAC legislative and regulatory expert
- Serves as the principal MD RA leader shaping and implementing the extremely fast pace and changing regulatory platform in key region.
- Proactively monitors ASPAC HA activity through systematic review of regulatory requirements.
- Identifies, cultivates, and nurtures relationships with ASPAC HAs necessary to proactively monitor regulatory changes and trends.
- Assesses changes in ASPAC regulatory policy and analyzes impact on MD RA and individual Business Units.
- Provides consistent and timely information to Sr. Director, MD Global Regulatory Intelligence on the dynamic global regulatory landscape.
- Manage J&J and Trade Assn. responses to proposed ASPAC regulatory changes.
Functional and Technical Competencies:
- Knowledge of China, Japan, India and other ASPAC 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, HAs, and trade associations to efficiently monitor regional regulatory policy.
- Strategic thinking and ability to partner with key external HA stakeholders at senior levels.
- Connect - Must develop and maintain regional relationships with key stakeholders (HAs, 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 across MD.
- Deliver - Ability to achieve results under demanding time constraints with expansive and changing priorities.
EDUCATION & EXPERIENCE REQUIREMENTS:
- 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.