About the role
AI summarisedThe Associate Director Regulatory Affairs for Diabetes Care at Abbott is responsible for developing and executing regulatory strategies for products in the Asia Pacific region. This role involves leading regulatory professionals, influencing legislation and guidelines through engagement with agencies and trade associations, managing budgets, and ensuring compliance across product lifecycle activities. The position requires a strong scientific background and extensive experience in regulatory affairs within healthcare industries.
HealthcareOnsite
Key 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
- 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