Regulatory Affairs Manager II - SGP

Description:

Job Description

Primary Function / Primary Goals / Objectives:

The Manager, Regulatory Affairs (RA) serves as the primary 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 of compounds in late-stage development and marketed products within the JAPAC region. With knowledge in regional regulatory requirements, the role acts as a subject matter expert for assigned countries, continuously monitoring and interpreting regulatory policy and intelligence relevant to those markets. In addition, the incumbent represents the RA function in cross-functional initiatives being led out of the Area office.

Major 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 Drug/ 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/compounds 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.

Qualifications

Education / Experience Required:

• Bachelor’s degree in pharmacy, Pharmacology, Biology, or a related scientific discipline (advanced degree preferred).

• Minimum of 5 years’ experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with at least 3 years’ hands-on experience in JAPAC regulatory affairs, end to end experience with New Drug Registrations, Health Authority Interactions and Clinical Trial Applications, with strong sensitivity and understanding of the cultural and business practices across the JAPAC region.

• Comprehensive knowledge of the regulatory requirements and processes across JAPAC countries, with demonstrated expertise in navigating local regulations, submissions, and health authority interactions.

• Experience working with Oncology compounds would be an advantage.

• Solid business acumen developed through participation in cross-functional projects and assignments.

• Demonstrated interpersonal and influencing skills, with a proven ability to communicate strategic and tactical regulatory issues clearly to management and diverse stakeholders.

• Strong personal development and motivational skills; committed 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, and cross-cultural environment.

Accountability / Scope:

• The incumbent will:

o manage assigned compounds and projects

o ensure prioritization of regulatory plans and execute those in line with business priorities.

• The incumbent is accountable for representing RA to the area commercial organization and ensuring that business priorities are communicated and integrated into the global regulatory strategies.

• The incumbent acts as the representative for RA on the cross-functional teams for the Area.

• The incumbent is expected to communicate changes in regulatory requirements that may impact on the data requirements or timelines for gaining and/or maintaining marketing authorization applications.

• The incumbent is responsible for ensuring regulatory compliance for the assigned compounds/products.

Problem Solving:

• The incumbent is expected to be able to identify potential issues that may impact the regulatory strategy and timeline for assigned projects/products and to develop solutions to mitigate the risk and outcome.

• The incumbent should have strong communication and negotiation skills to reach mutually agreeable solutions on issues with regulatory agencies, affiliates and regional cross functional stakeholders.

• The incumbent is expected to monitor the regulatory landscape and to identify trends within the region that may have a material impact on the business and adapt strategies where necessary.

Teleconferences (outside of office hours)

Represent JAPAC Area RA in GRPT meetings