Senior Associate Regulatory Affairs

Cliniminds; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A global pharma consulting company is seeking a Senior Associate in Regulatory Affairs to join their remote team. The ideal candidate will have extensive experience in biosimilars and regulatory compliance. Responsibilities include reviewing ACTD/eCTD documents and ensuring submission readiness. This role offers an attractive salary and the opportunity to shape biosimilar development across APAC markets.

Benefits

Attractive Salary

Qualifications

• 8-10 years in regulatory dossier compilation, preferably biosimilars.
• Proficient in ACTD & eCTD format and submission tools.

Responsibilities

• Conduct content and technical reviews of ACTD/eCTD modules.
• Perform document quality checks for regulatory accuracy.
• Draft and format CTD Modules.

Skills

Attention to Detail

Regulatory Science

Document Formatting

Cross-Functional Coordination

Education

M. Pharm

B.Pharm

Life Sciences

Tools

ACTD

eCTD

Job description

Immediate Joining | Remote | Full-time | Attractive Salary | Global Pharma Consulting Company

Are you a seasoned regulatory expert with strong experience in Biosimilars and deep knowledge of the ASEAN regulatory landscape? Join our growing team and help shape the future of biosimilar development and approvals across key APAC markets.

As a Senior Associate Regulatory Affairs, you'll conduct Level 1 reviews and QC of ACTD/eCTD documents, draft CTD Modules, and coordinate submission workflows. This role is perfect for detail-focused professionals passionate about regulatory science and compliance.

Key Responsibilities:

1. Conduct content and technical reviews of ACTD/eCTD modules
2. Perform document quality checks (QC) for regulatory accuracy
3. Draft and format CTD Modules (1 to 3)
4. Collaborate with SMEs and publishing vendors for submission readiness
5. Track document timelines and maintain version control
6. Stay updated with APAC regulatory and biosimilar guidance

Requirements:

1. M. Pharm / B.Pharm / Life Sciences background
2. 8-10 years in regulatory dossier compilation (preferably biosimilars)
3. Proficient in ACTD & eCTD format and submission tools
4. Excellent English writing and document formatting skills
5. Team player with strong cross-functional coordination skills