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- Lead submissions and regulatory responses for new products in APAC/Asia/ASEAN.
- Develop efficient submission strategies for regional regulatory approvals.
- Foster cross-departmental collaboration for regulatory insights.
- Act as the primary internal regulatory contact for the region.
- Standardize regulatory processes to improve efficiency.
- Integrate regulatory information management systems.
- Support innovation and business development projects.
- Monitor regional regulatory changes and assess their impact.
- Gather competitive intelligence on regulatory matters.
- 5+ years in APAC/Asia/ASEAN regulatory affairs (pharmaceutical, medical devices, consumer health)
- Experience in new registrations/variations/indications/renewals.
- Degree in Pharmacy, Life Sciences (or in a relevant field).
- Expertise in regional regulatory principals and experience managing communication and collaborations with health authorities.
- Strong multitasking, communication skills and great sense of team-work.
Regional Regulatory Affairs, Associate Manager - Singapore - INTEGRITY PARTNERS PTE. LTD.
Description
Roles & ResponsibilitiesPosition Overview: As a Regulatory Affairs Manager, you will lead submissions and streamline regulatory processes to ensure product approvals in the APAC/Asia/ASEAN markets, while fostering collaboration and compliance with regional regulations.
Key Responsibilities
Requirements
To apply, submit your most updated resume showcasing relevant qualifications and experience.
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Principal Consultant: Cheong Yee Yin | Registration Number: R | EA License Number: 17C8502
Tell employers what skills you haveFDA
Regulatory Compliance
Regulatory Affairs
Healthcare
Information Management
Oncology
ISO
Regulatory Strategy
Channel
Clinical Trials
Compliance
Medical Devices
Competitive Intelligence
Communication Skills
Regulatory Requirements
Life Sciences
Business Development
Regulatory Submissions