Senior Regulatory Affairs Specialist

Philippines - Philippines

Monthly Salary: Not Disclosed

Posted on: 03-11-2025

Vacancies: 1 Vacancy

Job Summary

Position: Senior Regulatory Affairs Specialist
Working hours: EST Business Hours
Salary Range : 3.000 to 5.500 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.

Position: Senior Regulatory Affairs SpecialistWorking hours: EST Business HoursSalary Range : 3.000 to 5.500 Usd Monhtly Based on ExperienceType of contract: Independent Contractor Agreement.100% Remote position open for LATAM Philippines and South AfricaAbout the Company:Our Company client is a res...

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.