Senior Director/Director, Global Regulatory Affairs - Norwood, United States - Corbus Pharmaceuticals

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, 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.

Qualifications and Experience:

• Bachelor's Degree in life sciences
• Higher degree preferred or equivalent experience
• 15+ years' experience in biotech or pharma with 10+ years in Regulatory Affairs
• Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA.
• Experience with filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and Priority Medicines Initiatives (PRIME) and other accelerated regulatory pathways ideal.
• Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.

Qualities:

• Demonstrate a collaborative leadership style within the Product Development Team when providing regulatory expertise.
• Prepared to be hands-on as well thinking strategically.
• Communicate well with internal and external stakeholders.
• Be able to effectively articulate to Senior Management regulatory risk and the potential impact.