Director/Senior Director, Global Regulatory Affairs

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Norwood, United States Corbus Pharmaceuticals Full time

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.


Qualifications and Experience:


  • Bachelor’s Degree in life sciences
  • Higher degree preferred or equivalent experience
  • 10+ years’ experience in biotech or pharma with 7+ 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.


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.


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.


Corbus Culture:


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 what’s best for patients.


About Corbus:


Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer. Corbus’ current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGFβ and an antibody drug conjugate targeting tumors expressing nectin-4. Corbus is headquartered 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.

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