Senior Manager, Regulatory Affairs

Responsibilities

• Lead and execute regional Regulatory Affairs (RA) initiatives for the JAPAC region in partnership with global and affiliate teams.
• Serve as the primary RA liaison for Allergan Aesthetics products, ensuring clear communication with local health authorities and affiliate teams.
• Develop and implement Area Regulatory Strategies and plans for assigned projects within the JAPAC region.
• Assess scientific and technical data for regulatory submissions to ensure alignment with regional requirements and identify potential gaps.
• Collaborate cross-functionally with Commercial, Medical Affairs, Market Access, and Clinical Development teams to mitigate regulatory risks.
• Monitor regional regulatory trends and emerging policies to assess business implications and develop proactive strategies.
• Support R&D and clinical operations in achieving timely approvals for clinical trial applications.

Requirements

• Bachelor’s degree in Bioengineering, Pharmacy, Pharmacology, Biology, or a related scientific discipline.
• Minimum of 7 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry.
• At least 5 years of hands-on experience in JAPAC regulatory affairs.
• Proven end-to-end experience with New Device Registrations in Japan and China.
• Demonstrated experience with Health Authority interactions and Clinical Trial Applications.
• Strong understanding of the cultural and business practices across the JAPAC region.

Preferred Qualifications

• Advanced scientific degree.
• Early development experience, including exposure to the concept phase and adaptive clinical trial designs.
• Strong business acumen and experience participating in cross-functional global projects.

About the Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience, and our Allergan Aesthetics portfolio.