Senior Regulatory Affairs Specialist

Position : Senior Regulatory Affairs Specialist

Working hours : EST Business Hours

Salary Range : 3.00 to 4.500 Usd Monhtly Based on Experience

Type of contract : Independent Contractor Agreement.

100% Remote position open for LATAM, Philippines and South Africa

About the Company :

Our Company client is a   research and development (R&D) company specializing in novel devices and drugs for the treatment of cancer and other diseases

Responsabilities :

Prepare, format, and submit high-quality regulatory submissions to health authorities, including the FDA and EMA (e.g., INDs, NDAs, MAAs, DSURs, Scientific Advice packages).

Manage end-to-end electronic Common Technical Document (eCTD) submissions using publishing software such as Lorenz DocuBridge.

Draft, review, and finalize regulatory documents, including cover letters and FDA-specific forms, ensuring alignment with agency guidelines and internal templates.

Collaborate with cross-functional teams (CMC, non-clinical, and clinical) to compile, QC, and integrate content into submission-ready formats.

Ensure all submission components meet formatting, technical, and regulatory standards using Microsoft Word templates and PDF tools.

Maintain submission archives and ensure regulatory documents are version-controlled and compliant with applicable regulations.

Support regulatory timelines and assist in planning and tracking submission deliverables and milestones.

Troubleshoot and resolve technical issues related to publishing tools and document formatting.

Provide guidance and support to internal stakeholders on submission standards and processes.

Requirements

• 4+ years of experience in regulatory filings to both FDA and EMA (IND, Scientific Advice, NDA, MAA, DSUR reports, etc.)
• Familiarity with CMC, non-clinical, and clinical modules a plus.
• Ability to draft cover letters and complete FDA forms.
• Experience with IND (Investigational New Drug) and NDA (New Drug Application) submissions.
• ECTD publishing software and sage Microsoft Word templates are advantageous.
• Hands-on experience with eCTD publishing software specifically Lorenz DocuBridge from Lorenz is  plus .