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Director/Associate Director, Regulatory Affairs (Strategy)

  • Permanent
  • Anywhere

Website Corbus Pharmaceuticals

Corbus Pharmaceuticals

Company : Corbus Pharmaceuticals

Country: United States

Location : Park Place Industrial Park, Massachusetts

Post: Fri, 10 Sep 2021 04:59:38 GMT

Expires: Sun, 10 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Job Description

JOB DESCRIPTION:

The Director/Associate Director of Regulatory Affairs role will work to develop and implement regulatory strategy on assigned programs. This person will work closely with cross-functional teams and subject matter experts to support development and finalization of study-related regulatory documents, manage various routine regulatory submissions, assist in preparation and related submissions for meetings with various Health Authorities. Ensure compliance with safety and periodic reporting requirements for investigational drugs. The person in this role will report to Sr. Director of Regulatory Affairs and must be able to operate with a minimum of supervision.

RESPONSIBILITIES:

Serve as regulatory lead on clinical study teams

Collaborate with regulatory and cross-functional colleagues on clinical document reviews

Preparation and submission of regulatory filings in collaboration with Regulatory Operations

Collaborate with study teams and keep study teams informed of regulatory activities related to such study

Expedited safety reporting, as needed

Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, and pediatric investigation plans

Participate in negotiations with regulatory agencies to resolve issues and coordinate preparation and submission of responses to various Health Agencys questions

Act as primary regulatory liaison with medical writers, clinical, statistics, and non-clinical teams as well as external CROs to provide regulatory support for trial initiation and ongoing maintenance needs

Review technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines, and requirements including SOPs

Participate in regulatory intelligence activities, monitor advisory committees, regulatory guidelines and trends.

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