Oncology Regulatory Affairs Lead – JAPAC (Contract)

MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD; Singapore; Presencial; SGD 117.000 - 140.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory Affairs JAPAC

Oncology

Regulatory Strategy

Educación

Bachelor’s degree in pharmacy, Pharmacology, Biology

Descripción del empleo

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.