Associate Director Regulatory Affairs, APAC

JOB DESCRIPTION:

We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

MAIN PURPOSE OF ROLE

The function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet required legislation. Additionally, the individual will develop and supervise regulatory professionals. The individual has division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally. The individual will influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual will plan, direct, and coordinate the regulatory affairs activities related to products in the Asia Pacific region.

MAIN RESPONSIBILITIES

• Builds relationship at local and regional level directly as Abbott or through Trade Associations
• Ensures that agreed regulatory strategies for Abbott Diabetes Care in the Asia Pacific region are efficiently implemented, and are maintained in-line with changing regulatory needs and business needs
• Develops regulatory strategy on new product categories to allow business development in new segments
• Understands regulations, regulatory procedure and related institutions as well as trend in regulations
• Develops and implements internal and external strategies to proactively influence legislation / guidelines with impact on Abbott Diabetes Care in the Asia Pacific region either directly or through Trade Associations
• Provides strategy and direction to teams involved in agency hearings at Affiliate level
• Supports product complaints, anticipating authorities expected response
• Identifies areas of margin improvement
• Manages assigned budgets as appropriate
• Provides regulatory leadership and expertise to licensing colleagues
• Trains, develops and manages an effective team at Area and Affiliate level

REQUIREMENTS

• Bachelor's Degree in a scientific discipline (e.g., biomedical engineering,pharmacy, chemistry, pharmacology, life science.)
• A relevant Masters Degree is preferred.
• At least 2-3 years global experience.
• 7+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Experience in nutrition/medical device/pharmaceutical industry and international business.
• Expertise in due diligence, Company integration and rationalization of manufacturing facilities from the regulatory perspective
• Must have the ability to convince division management at all levels to support the regulatory needs.
• Must have the ability to present complex scientific data to meet the needs of individual regulatory agencies, and the scientific and management skills to negotiate.
• Routinely identifies areas of regulatory or compliance risk, and establishes programs to reduce risk.
• Resourcefully directs the development of creative solutions to unusually complicated regulatory and systems problems.
• Problem solving, creative and effective solution skills