PRIMARY FUNCTION/OBJECTIVE:

The primary function of the Senior Manager, Regulatory Affairs (RA) is to act as the primary representative of the regulatory affairs organization for all aspects related to the assigned therapeutic area. The role will cover cross Therapeutic Area (Allergan Aesthetics) products of responsibility in JAPAC (Australia, China, Japan, and Asia).  The incumbent will have knowledge of the regulatory requirements of the countries within the region, and will combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation.  The incumbent will also represent RA in any cross-functional initiatives being led out of the Intercontinental commercial office. 

CORE JOB RESPONSIBILITIES:

• Lead and execute regional Regulatory Affairs (RA) initiatives for JAPAC in partnership with global, area, and affiliate teams; ensure timely project completion and efficient communication and implementation of plans.
• Serve as the primary RA liaison to affiliate teams for assigned programs, maintaining clear and productive communication channels.
• Serve as primary RA point of contact with local health authorities (through affiliate RA personnel); prepare teams for agency consultations by aligning briefing materials with the regulatory strategy, and ensure outcomes are communicated promptly to stakeholders.
• Assess and review scientific and technical data provided by subject matter experts for regulatory submissions, ensuring alignment with JAPAC and regional requirements, identifying gaps, and developing mitigation strategies as needed.
• Effectively present regulatory data to RA affiliates and ensure complete and timely responses to authorities for Clinical trial applications, New Asset/ New indication applications and any other assigned applications.
• Collaborate cross-functionally with Commercial, Medical Affairs, Market Access, Clinical Development, and CMC teams, represent the regulatory function and provide strategic input to enable product registrations, mitigate regulatory risks, and ensure compliance.
• Develops Area Regulatory Strategy and implements Regulatory Plan for assigned projects in JAPAC region in conjunction with the Global Regulatory Lead, RA Affiliate team and RA submission management.
• Represent regional and affiliate regulatory strategies and requirements in Global Regulatory Product Teams (GRPT), ensuring alignment across global, regional, and local stakeholders and regulatory leadership forums.
• Monitor and analyze trends in the regional regulatory environment and emerging policies; provide updates, assess business implications, and develop strategies to address regulatory changes affecting product portfolios.
• Support R&D, affiliate regulatory teams, and clinical operations in achieving timely approvals for clinical trials applications.
• Oversee regulatory compliance for assigned products/devices in JAPAC; support implementation and monitoring of remediation plans to address identified compliance gaps.
• Proactively identify, escalate, and manage regulatory risks throughout the product life cycle, recommending solutions to management as required.
• May participate in due diligence, portfolio planning, or integration activities to support business expansion or product acquisitions.
• Contribute to process improvement initiatives within the RA function and foster a culture of continuous improvement, knowledge sharing, and best practices.