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Abbott

Associate Director Regulatory Affairs -Diabetes Care

Abbott
HealthcareSingaporeOnsitePosted 4 weeks ago
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About the role

AI summarised

The Associate Director Regulatory Affairs combines scientific, regulatory, and business knowledge to ensure products developed, manufactured, and distributed meet all required legislation. This role involves leading regulatory affairs activities for the Asia Pacific region, influencing changing regulations, and providing expert guidance to internal teams.

HealthcareOnsite

Key Responsibilities

  • Develops and implements regulatory strategies for new product categories to enable business development in new segments.
  • Ensures efficient implementation and maintenance of agreed regulatory strategies for Abbott Diabetes Care across the Asia Pacific region in line with evolving needs.
  • Builds relationships at local and regional levels, either directly or through Trade Associations.
  • Develops internal and external strategies to proactively influence legislation and guidelines impacting Abbott Diabetes Care in the Asia Pacific region.
  • Provides regulatory leadership, strategy, and direction to teams involved in agency hearings at the Affiliate level.
  • Supports product complaints by anticipating expected responses from regulatory authorities.
  • Trains, develops, and manages an effective team at the Area and Affiliate levels.

Requirements

  • Bachelor's Degree in a scientific discipline (e.g., biomedical engineering, pharmacy, chemistry, pharmacology, life science).
  • 7+ years of experience in regulatory affairs preferred.
  • 2-3 years of global experience required.
  • Experience in the nutrition, medical device, or pharmaceutical industry with international business exposure.
  • Expertise in due diligence, Company integration, and rationalization of manufacturing facilities from a regulatory perspective.
  • Ability to convince division management at all levels regarding regulatory needs.
  • Proven ability to present complex scientific data to meet the needs of individual regulatory agencies and negotiate effectively.
  • Routinely identifies areas of regulatory or compliance risk and establishes programs to mitigate that risk.