Regulatory Affairs Manager – Oncology (Contract/ Pharma)

Manpower Singapore; Singapore; On-site; SGD 77,000 - 128,000; Full time

Job summary

Manpower Singapore is seeking a Regulatory Affairs Manager – Oncology for a 12-month contract, based in Buona Vista. The role serves as JAPAC RA representative for R&D and commercial, driving regulatory strategies for late-stage and marketed oncology products.

You will liaise with local health authorities, lead RA initiatives with cross-functional teams, review data for submissions, and ensure timely registrations and label updates across JAPAC.

Qualifications

• Bachelor's degree in pharmacy, pharmacology, biology or related scientific discipline.
• Minimum 5 years in Regulatory Affairs in pharma/biotech, with JAPAC exposure and experience with NDIs and health authority interactions.
• Experience managing regulatory strategies across JAPAC regions and liaising with affiliates.

Responsibilities

• Lead JAPAC regional RA initiatives with global and affiliate teams; ensure timely project completion.
• Serve as primary RA liaison to affiliate teams for assigned programs; maintain clear communication.
• Coordinate with local health authorities through affiliate RA teams; prepare briefing materials aligned with regulatory strategy; communicate outcomes to stakeholders.
• Assess scientific/technical data for regulatory submissions; identify gaps and mitigation strategies.
• Present regulatory data to affiliates and ensure timely responses to authorities for clinical trials and regulatory submissions.
• Collaborate with cross-functional teams (Commercial, Medical Affairs, Market Access, Clinical Development, CMC) to enable product registrations and mitigate risks.

Skills

Regulatory affairs

JAPAC experience

Cross-functional collaboration

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.

About the role

• 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.

Key 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
• Proactively identify, escalation, manage regulatory risks throughout the product life cycle, recommending solutions to management as required

About you

• 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
• 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