Manager, Regulatory Affairs

Position Overview:
Primary responsibility of Manager, Regulatory Affairs is, managing on-going regulatory operations. Secondary, he/ she support Director Regulatory Affairs for developing the team as best in the industry. Additionally, provide strategic advises for regulation, life cycle management upon regulatory/governmental policy change, positioning and branding. He/ she should advise(s) to both Director of Regulatory Affairs and other internal stakeholders, including Japan senior management team to achieve/drive business goals, if any

Duties & Responsibilities:

  • Exhibits an ability to translate regulatory/quality needs into clearly defined goals, objectives, strategies, and tactics to drive the business. Accountable for gaining and driving cross functional support(s) from internal stakeholders (Quality Control and Marketing team).
  • Identifies current regulatory and quality requirement(s) trends. Determines product/service lifecycle implications and makes recommendations to maintain market competitiveness and to achieve sustainable economic success.
  • Understands available methods to execute primary research (VOC) that are necessary to drive portfolio/product decisions. Can identify market opportunities through VOC/secondary research and take action by implementing and managing solutions.
  • Demonstrates basic knowledge of marketing disciplines and concepts necessary for building a business & marketing plans and identifies the appropriate market. Has the ability to understand market trends and competitive positioning.
  • Demonstrates regulatory/quality acumen, logical thinking and good communications in the general business environment.
  • Works effectively across cross functional groups including but not limited to IT, communications, operations, and sales.
  • Support to take leadership position in shaping regulatory policy dialogues to governmental stakeholders.

Qualifications & Requirements

  • Bachelors and Advanced degree in related field, or equivalent work experience, preferred.
  • 8-12 years experience in related field, preferred.
  • Basic command of English.

What is expected of you and others at this level

  • Provides good influence and opportunities to develop professional staffs
  • Shows good ability to debate with scientific knowledge.
  • Functions as internal consultant to other divisions (i.e.: Quality, Supply Chain and Marketing team) for developing and implementing policies and procedures to achieve organizational goals
  • Assists in the development of functional strategy
  • Understands an extended impact on work processes, outcomes, and customers
  • Interacts with internal and/or external leaders, including senior management
  • Persuades others into agreement in sensitive situations while maintaining positive relationships

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.