Regulatory Affairs (RA) is one of the most critical and stable career paths in biotechnology, pharmaceuticals, and medical devices. As regulatory requirements become stricter across Asia-Pacific, companies are actively hiring professionals who can navigate approvals, submissions, and compliance across multiple markets.
If you’re exploring regulatory affairs jobs in biotech, this guide explains what the role involves, salary expectations, required skills, and how to break into Regulatory Affairs in 2026.
1. What Are Regulatory Affairs Jobs?
Regulatory Affairs professionals ensure that biotech and life sciences products comply with national and international regulations throughout their lifecycle.
They work closely with:
- R&D teams
- Quality and manufacturing
- Clinical research
- Health authorities
RA roles exist across drug development, medical devices, diagnostics, and combination products.
2. Common Regulatory Affairs Job Titles
You may encounter different titles depending on seniority and industry:
- Regulatory Affairs Associate
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Regulatory Operations Specialist
- CMC Regulatory Affairs Specialist
- Medical Device Regulatory Specialist
- Regulatory Submissions Manager
Titles vary, but the core responsibilities remain similar.
3. Key Responsibilities in Regulatory Affairs
Typical responsibilities include:
- Preparing and managing regulatory submissions
- Interacting with health authorities
- Ensuring compliance with regional and global regulations
- Supporting product registrations and renewals
- Reviewing labeling and promotional materials
- Monitoring regulatory changes
- Supporting audits and inspections
Regulatory Affairs is a strategic role, not just documentation.
4. Regulatory Affairs Jobs by Industry
Biotechnology & Pharmaceuticals
- IND, NDA, MAA submissions
- CMC documentation
- Clinical trial applications
Medical Devices & MedTech
- Technical files
- Risk management documentation
- ISO 13485 compliance
CROs
- Regulatory submissions for multiple sponsors
- Global regulatory coordination
5. Regulatory Affairs Salaries in APAC (2026)
Entry-Level:
Regulatory Affairs Associate: SG$4,000 – SG$6,000 / RM 3,500 – RM 5,500 / AU$65,000 – AU$85,000
Mid-Level:
Regulatory Affairs Specialist: SG$6,500 – SG$9,500 / AU$90,000 – AU$120,000
Senior Roles:
Regulatory Affairs Manager: SG$10,000 – SG$15,000+ / AU$130,000 – AU$160,000+
Regulatory roles tend to offer steady salary growth and strong job security across APAC.
6. Skills Needed for Regulatory Affairs Jobs
Technical & Regulatory Skills
- Knowledge of regulatory frameworks
- Dossier preparation and lifecycle management
- Regulatory strategy development
- Labeling and compliance review
Soft Skills
- Attention to detail
- Stakeholder communication
- Project management
- Ability to interpret complex regulations
7. How to Get a Job in Regulatory Affairs
1️⃣ Build regulatory exposure
Many professionals transition from:
- QA/QC
- Clinical research
- R&D
- Manufacturing
2️⃣ Learn regulations
Understanding guidelines is essential.
3️⃣ Gain submission experience
Hands-on involvement in regulatory submissions significantly improves employability.
4️⃣ Consider CRO roles
CROs often offer faster entry into Regulatory Affairs careers.
5️⃣ Use specialized biotech job platforms
Regulatory roles are often missed on generic job boards.
Browse current regulatory affairs jobs here:
👉 https://apacbiojobs.com/jobs/regulatory-affairs-compliance
8. Career Progression in Regulatory Affairs
A typical path:
- Regulatory Affairs Associate
- Regulatory Affairs Specialist
- Senior RA Specialist
- Regulatory Affairs Manager
- Head of Regulatory Affairs
Experienced professionals may move into:
- Regulatory strategy
- Global regulatory leadership
- Consulting roles
Conclusion
Regulatory Affairs offers one of the most stable, respected, and well-compensated career paths in biotech and life sciences. As APAC regulations evolve, demand for skilled RA professionals will continue to grow.
Explore current Regulatory Affairs opportunities across Asia-Pacific on APACBioJobs.com.