Job Title: Clinical Regulatory Affairs Specialist - Small Molecule

Location: Remote

Job Summary:

We are seeking an experienced Clinical Regulatory Affairs Specialist with a strong background in clinical regulatory affairs, Trial Master File (TMF) management, and small molecule drug development. The ideal candidate will have extensive experience supporting global clinical trials, preparing regulatory submissions, and ensuring compliance with FDA, EMA, Health Canada, and ICH guidelines. While familiarity with CMC regulatory activities is beneficial, this role is primarily focused on clinical regulatory operations and TMF management.

Key Responsibilities:

Lead and support clinical regulatory activities for small molecule development programs from early-phase through late-stage clinical trials.
Manage and maintain Trial Master Files (TMF/eTMF), ensuring inspection readiness and compliance throughout the clinical trial lifecycle.
Prepare, review, compile, and submit regulatory applications, including INDs, CTAs, NDAs, BLAs (where applicable), amendments, annual reports, and responses to Health Authority queries.
Coordinate global regulatory submissions and ensure timely delivery of required documentation.
Review clinical documents, including study protocols, Investigator''s Brochures (IB), informed consent forms (ICFs), Clinical Study Reports (CSRs), and safety documentation.
Ensure compliance with ICH-Google Cloud Platform, FDA, EMA, Health Canada, and other applicable global regulatory requirements.
Collaborate closely with Clinical Operations, Medical Writing, Clinical Development, Pharmacovigilance, Quality Assurance, Biostatistics, and Data Management teams.
Support regulatory inspections and audits by maintaining complete, accurate, and inspection-ready TMFs.
Track regulatory commitments, submission timelines, and health authority communications.
Contribute to regulatory strategies for global clinical development programs.

Required Qualifications:

Bachelor''s or Master''s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related discipline.
7–10+ years of experience in Clinical Regulatory Affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience supporting small molecule clinical development programs.
Strong hands-on experience with Trial Master File (TMF/eTMF) management using platforms such as Veeva Vault TMF, DIA TMF, or equivalent systems.
Proven experience preparing and supporting IND, CTA, NDA, and other clinical regulatory submissions.
Thorough understanding of ICH-Google Cloud Platform, FDA, EMA, Health Canada, and global regulatory requirements.
Experience working with cross-functional clinical teams throughout the clinical development lifecycle.
Excellent project management, organizational, written, and verbal communication skills.
Ability to manage multiple priorities in a fast-paced, deadline-driven environment.

Preferred Qualifications:

Experience supporting global, multi-country clinical trials (Phase I–IV).
Experience interacting with Health Authorities and responding to regulatory questions.
Working knowledge of CMC regulatory activities for small molecule products is preferred.
Experience with electronic regulatory document management systems and Regulatory Information Management (RIM) tools.
RAC certification or other regulatory affairs certifications are considered an asset.
Preferred Skills

Clinical Regulatory Affairs:

Small Molecule Drug Development
Trial Master File (TMF/eTMF)
Veeva Vault TMF
IND, CTA, NDA Submissions
ICH-Google Cloud Platform Compliance
FDA, EMA, Health Canada Regulations
Clinical Trial Documentation
Regulatory Strategy
Inspection Readiness
Cross-Functional Collaboration
Clinical Operations

Clinical Regulatory Affairs Specialist - Small Molecule

Key skills

About this role