Associate Director, Regulatory Affairs, JAPAC

The Associate Director, Regulatory Affairs (RA) serves as the JAPAC representative of the regulatory affairs function within both the R&D and commercial organizations for all matters related to assigned therapeutic areas and products. The incumbent is responsible for defining, implementing, and delivering Area and Affiliate regulatory strategies across a portfolio spanning early development, late development, and marketed products within the JAPAC region. The role acts as a subject matter expert for assigned countries, monitoring, interpreting, and influencing regulatory policy and intelligence. The incumbent represents the RA function in cross-functional initiatives and mentors and develops the regulatory team for the assigned therapeutic areas and products.

• Provide mentorship and development to team members; represent Therapeutic Area Head at internal and external meetings and initiatives.
• Lead and execute regional Regulatory Affairs initiatives for JAPAC in partnership with global, area, and affiliate teams; ensure timely project completion and effective communication of plans.
• Serve as the primary RA liaison to affiliate teams for assigned programs, maintaining clear and productive communication channels.
• Act as primary RA point of contact with local health authorities; prepare teams for agency consultations by aligning briefing materials with regulatory strategy and ensuring timely communications to stakeholders.
• Assess and review scientific and technical data for regulatory submissions, ensuring alignment with JAPAC and regional requirements; identify gaps and develop mitigation strategies.
• Present regulatory data to RA affiliates and ensure complete and timely responses to authorities for Clinical Trial Applications, New Drug/New Indication applications, and other assigned submissions.
• Collaborate cross-functionally with Commercial, Medical Affairs, Market Access, Clinical Development, and CMC to enable product registrations, mitigate regulatory risks, and ensure compliance.
• Develop Area Regulatory Strategy and implement Regulatory Plans for assigned projects in JAPAC with Global Regulatory Lead, RA Affiliate team, and RA submission management.
• Represent regional and affiliate regulatory strategies in Global Regulatory Product Teams (GRPT) for alignment across global, regional, and local stakeholders.
• Monitor regulatory trends in the region; provide updates, assess business implications, and develop strategies to address changes affecting product portfolios.
• Support R&D, affiliate regulatory teams, and clinical operations in achieving timely approvals for clinical trial applications.
• Lead development and delivery of training programs to build regional RA capability and team development.
• Oversee regulatory compliance for assigned products/compounds in JAPAC; support remediation plans to address identified gaps.
• Identify, escalate, and manage regulatory risks throughout the product life cycle; recommend solutions to management.
• 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 promote knowledge sharing and best practices.

• Bachelors degree in pharmacy, Pharmacology, Biology, or related scientific discipline (advanced degree preferred).
• Minimum of 7 years experience in Regulatory Affairs within the pharmaceutical/biotechnology industry, with at least 5 years JAPAC regulatory affairs experience, including end-to-end experience with Japan and China New Drug Registrations, health authority interactions, and clinical trial applications; strong cross-cultural understanding of JAPAC.
• Comprehensive knowledge of regulatory requirements across JAPAC countries; proven ability to navigate local regulations, submissions, and health authority interactions.
• Early development experience starting from Phase 1 trials, including exposure to adaptive trial designs.
• 1-2 years of recent regulatory experience with medical devices and/or combination products.
• Experience with immunology compounds is preferred.
• Proven track record of supporting capability development and team growth within Regulatory Affairs; strong business acumen from cross-functional projects.
• Experience in resource planning, line management, or direct team leadership is advantageous.
• Strong interpersonal and influencing skills; ability to communicate regulatory issues clearly to management and diverse stakeholders.
• Commitment to ongoing professional growth and supporting the growth of others.
• Ability to work independently, manage multiple priorities, and deliver high-quality outcomes in a dynamic, fast-paced, cross-cultural environment.

• Represent RA to the area commercial organization and ensure alignment of business priorities with global regulatory strategies.
• Act as the RA representative on cross-functional Area teams.
• Communicate regulatory changes that may impact data requirements or timelines for marketing authorization.
• Deputize the Therapeutic Area Head for assigned projects; prioritize regulatory plans and execute in line with business priorities.
• Manage assigned compounds and projects; mentor the team on technical and leadership capabilities.

• Identify issues that may impact regulatory strategy and timelines; develop mitigation solutions.
• Demonstrate strong communication and negotiation skills to reach solutions with regulatory agencies, affiliates, and cross-functional stakeholders.
• Monitor regulatory landscape for regional trends that could impact the business and adapt strategies as needed.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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Information :

• Company : Abbvie
• Position : Associate Director, Regulatory Affairs, JAPAC
• Location : Singapore
• Country : SG