Senior Director/Director

Job Description

General Description:

As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus' drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable.

Responsibilities:

Collaborate with the leadership team to develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible.

Proactively identifying regulatory risks and working with the Corbus Product Development Team to mitigate those risks.

Leading working groups tasked with developing regulatory submissions e.g. IND working group.

Overseeing clinical trials submissions performed by Contract Research Organizations (CRO) ensure timely and good quality submissions supportive of the overall

Providing regulatory input on safety documentation e.g. Development Safety Update Report (DSUR), Investigator's Brochure (IBs)

Providing regulatory input on clinical documentation as required e.g. Protocols, Clinical Study Reports (CSR)

Reviewing external communications e.g. Publications, Press Releases, Clinicaltrial.gov postings for regulatory compliance

Identifying and managing subject matter experts engaged to support regulatory activities

Ensuring that Corbus has a complete record of all regulatory submissions made by the company or on behalf of the company.