Regulatory Manager

Clinovo; United States; On-site; USD 100,000 - 140,000; Full time

Job summary

Clinovo is seeking a regulatory affairs professional to support a large, multicenter Phase 3 study and coordinate multi-regional CTAs with CROs. You will assemble internal regulatory documents and ensure timely submission across regions.

In this role, you will manage timelines within a multidisciplinary team, perform essential document reviews for site initiation, respond to health authority queries, assist with trial registrations, and archive submission materials for compliance.

Qualifications

• 6–10 years of industry experience required.
• Bachelor's or master's degree, or equivalent, required.
• RAC (Drugs) preferred.
• Direct experience managing clinical documentation related to clinical trial applications.
• Experience with US IND and EU CTIS.

Responsibilities

• Support start-up regulatory activities for a large, multicenter Phase 3 study.
• Assemble internal regulatory documentation for multi-regional CTAs and stage for CRO transmission.
• Interface with CROs to coordinate multi-regional CTA and Ethics Committee submissions.
• Provide project management within a multidisciplinary project team to ensure timely documentation.
• May carry out country-specific site essential document reviews for regulatory greenlight.
• Coordinate response preparations to health authority queries during CTA review.
• Support trial registrations in CT.gov or other global registries as needed.
• Ensure archival of all CT submission documents and amendments.

Skills

Regulatory submissions coordination

Project management

Cross-functional collaboration

CRO liaison

Education

Bachelor's degree or Master's degree

RAC (Drugs) preferred

Job description

• Support start-up regulatory activities for a large, multicenter, international Phase 3 study.
• Will assemble internal regulatory documentation to support multi-regional Clinical Trial Applications (CTAs), in collaboration with internal functional groups, and stage them for transmission to key clinical Contract Research Organizations (CROs).
• Will interface directly with CROs as needed to coordinate multi-regional CTA and Ethics Committee submissions.
• Will provide project management within a multidisciplinary project team environment, to ensure that necessary clinical trial documentation is available in a timely manner.
• May carry out country-specific site essential document reviews in support of the 'regulatory greenlight' process for site initiation. Will complete documentation of any essential document reviews.
• Coordinate response preparations to HA queries during review of CTAs
• Support trial registration activities in CT.gov or other global registries as needed for Regulatory compliance
• Ensure appropriate archival of all CT submission documents and amendments.
• Will provide support to the regulatory affairs/operations teams, as may be needed.

Desired Qualifications

• 6-10 years of industry experience is expected. Bachelor's or master's degree, or equivalent, required. RAC (Drugs) preferred. Direct experience managing clinical documentation related to clinical trial applications required; notably, both US IND and EU CTIS experience is expected.