Regulatory Affairs Manager – Oncology (Contract/ Pharma)

MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD; Singapore; On-site; SGD 117,000 - 140,000; Full time

Job summary

MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD is seeking a Regulatory Affairs Manager – Oncology for a 12-month contract in Singapore. The role leads JAPAC regulatory strategies for late-stage and marketed oncology products, coordinating with R&D and commercial teams.

The candidate will serve as the RA expert for JAPAC, monitor regulatory policy, and drive submissions and HA interactions across multiple markets. Teleconferences outside standard office hours are expected.

Qualifications

• Bachelor’s degree in a scientific discipline (pharmacy/pharmacology/biology).
• Minimum 5 years’ Regulatory Affairs experience in pharma/biotech.
• At least 3 years in JAPAC regulatory affairs with end-to-end experience in ND registrations, HA interactions, and CTAs.
• Solid understanding of regulatory requirements across JAPAC and cross-functional collaboration.

Responsibilities

• Lead regional RA initiatives for JAPAC with global and affiliate teams.
• Serve as primary RA liaison to affiliate teams for assigned programs.
• Coordinate with local health authorities via affiliate RA personnel and align briefing materials to regulatory strategy.
• Assess data for submissions and ensure alignment with JAPAC/regional requirements.
• Present regulatory data to affiliates and ensure timely responses to authorities for trials and registrations.
• Collaborate across Commercial, Medical Affairs, Market Access, Clinical Development, and CMC to enable product registrations.

Skills

Regulatory Affairs JAPAC

Oncology

Regulatory Strategy

Education

Bachelor’s degree in pharmacy, Pharmacology, Biology

Job description

Regulatory Affairs Manager – Oncology (Contract/ Pharma)

12 Months Contract

Location : Buona Vista

Industry : Pharmaceutical

Salary Up to $11,500 depending on experience

Working hours : Please note that the role includes expected teleconferences outside of standard office hours.

Job Description

• 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.
• 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.
• Acts as a subject matter expert for assigned countries, continuously monitoring and interpreting regulatory policy and intelligence relevant to those markets.
• 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, escal…? Actually the bullet line after above:
• 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.

Requirements

• Bachelor’s degree in pharmacy, Pharmacology, Biology, or a related scientific discipline
• 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 high 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
• Solid business acumen developed through participation in cross-functional projects and assignments.