Senior Director/Director, Global Regulatory Affairs

4 weeks ago

Oklahoma City, United States CareerBuilder Full time

Senior Director/Director, Global Regulatory Affairs

Full-time
Our passion. Our purpose. At Corbus, it starts at our core.
We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow.At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on whats best for patients.
About Corbus
Corbus is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: 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, an anti-integrin monoclonal antibody that blocks the activation of TGF? expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 (CB1) receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visitcorbuspharma.com. Connect with us onTwitter,LinkedInandFacebook.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer
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 teamto 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), Investigators 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.
Qualifications and Experience:
Bachelors 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.

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