Associate Director, Regulatory Affairs

Corbus Pharmaceuticals Inc•Norwood, MA

2d•Hybrid

About The Position

As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus’ drug development by leading the preparation and/or oversight of regulatory submissions and inputting into the regulatory strategy as the US regulatory lead for Corbus’ programs. This role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly.

Requirements

Bachelor’s Degree in life sciences or Pharmacy.
8-10 years in Regulatory Affairs, preferably in a small biotech.
Experience of regulatory submissions to the FDA including but not limited to INDs, Formal FDA Meetings and PSPs.
Experience with preparing and filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and other accelerated regulatory pathways ideal. Experience of BLA or NDA submissions desirable.
Contribute to Corbus’ Regulatory Intelligence process.
Demonstrate a collaborative leadership style within the Product Development Team when providing regulatory expertise.
A hands-on attitude and the ability to adapt to a rapidly changing environment.
A strategic thinker as well as a competent writer of regulatory documentation.
Outstanding communication (written and verbal) skills and willingness to share information and articulate regulatory risk and potential impact.
Ability to plan and execute projects to tight deadlines.
An excellent team player with a proven ability to manage projects as part of an interdisciplinary team.
Attention to detail essential.

Responsibilities

Act as the key contact to the FDA Divisions and build a good relationship with the FDA Regulatory Project Manager on behalf of Corbus.
Support in the development of Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible.
Lead the preparation and maintenance of submissions to the FDA including INDs, PSPs, meeting packages, Fast Track and Breakthrough Designations.
Proactively identifying regulatory risks and working with the Corbus Product Development Team to mitigate those risks.
Oversees clinical trials submissions performed by Contract Research Organizations (CRO) to ensure timely and good quality submissions.
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. Clinicaltrial.gov postings for regulatory compliance
Ensuring that Corbus has a complete record of all regulatory submissions made by the company or on behalf of the company.
Identifies and creates appropriate Regulatory processes (SOPs, WPDs etc) to ensure consistency and compliance.