Associate Director, Regulatory Affairs at Corbus Pharmaceuticals Inc

Norwood, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

26 May, 26

Salary

0.0

Posted On

25 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, FDA Liaison, Regulatory Strategy, INDs, PSPs, Fast Track, Breakthrough Designations, Risk Mitigation, CRO Oversight, Safety Documentation, Clinical Documentation, Regulatory Compliance, SOP Creation, Regulatory Intelligence, Collaborative Leadership, Strategic Thinking

Industry

Pharmaceutical Manufacturing

Description

Description 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. 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. 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. Corbus Culture: Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. About Corbus: Corbus is an oncology and obesity company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin 4-on cancer cells to release a cytotoxic payload and CRB-601, and anti-integrin monoclonal antibody which blocks the activation of TGFß expressed on cancer cells. Additionally, we are developing a cannabinoid receptor-1 (CB-1) inverse agonist as potential treatment for obesity. Corbus is headquarters in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook. Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

Responsibilities

This role supports drug development by leading the preparation and oversight of regulatory submissions and contributing to the regulatory strategy as the US regulatory lead for company programs. Key duties include acting as the primary contact with FDA Divisions and leading the preparation of various submissions like INDs, PSPs, and designation applications.