-
Regulatory Affairs Consultant
3 weeks ago
Connect Life Science Oklahoma City, United StatesRegulatory Affairs Consultant · Cambridge MA, Remote with occasional site time · Medical Device · 6 month contract - 40 hours per week · Competitve hourly rate · A MedTech company based in Massachusetts specializing in Class 2 Medical Device solutions are looking to hire a contr ...
-
VP, Regulatory Affairs
3 weeks ago
Vigilneuro Oklahoma City, United StatesVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of mo ...
-
Manager, Regulatory Affairs
3 weeks ago
The AES Corporation Oklahoma City, United StatesAt AES, we raise the quality of life around the world by changing the way energy works. Everyone makes an impact every day in our small, global teams. Apply here to start an extraordinary career today. · AES Clean Energy, a subsidiary of The AES Corporation global company, speci ...
-
Regulatory Affairs Specialist III
3 weeks ago
Paragonix Technologies, Inc. Oklahoma City, United StatesParagonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unpreced ...
-
Director Regulatory Affairs-CMC
3 weeks ago
Disc Medicine Oklahoma City, United StatesDisc Medicine is seeking a Director, Regulatory Affairs-CMC to serve as the Regulatory-CMC lead for Disc Medicine's small molecule program pipeline. This position will have close collaboration with the development teams and visibility to the executive leadership with meaningful o ...
-
Sr Director, Regulatory Affairs
3 weeks ago
HireMinds Oklahoma City, United StatesOur cutting-edge, vaccine client is seeking a · Sr. Director, Regulatory Affairs · (REMOTE) to their growing team This role will be accountable for developing regulatory strategies for their vaccine candidates with an emphasis on European requirements for early and late-stage a ...
-
Head, Global Regulatory Affairs
3 weeks ago
Corbus Pharmaceuticals Oklahoma City, United StatesOur 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 com ...
-
Director/Senior Director Regulatory Affairs
3 weeks ago
ScientaSearch Limited Oklahoma City, United StatesA clinical-stage biotech focused on Rare Diseases. This company utilizes antibodies to harness the bodies immune system to fight off disease. · The Role · This person ill serve as the GRL for the company's early stage proprietary pipeline as well as supporting partnered programs ...
-
Senior Manager Regional Regulatory Affairs
3 weeks ago
CSL Plasma Oklahoma City, United StatesSenior Manager Regional Regulatory Affairs page is loaded · Senior Manager Regional Regulatory Affairs · Apply · locations · Americas, US-PA, King of Prussia, CSL Behring · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R · CSL Behring is ...
-
Allergan Oklahoma City, United StatesDirector, Safety. Regulatory Affairs and Medical Affairs Quality Standards · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impac ...
-
Manager/Sr. Manager, Regulatory Affairs CMC
3 weeks ago
X4lifesciences Oklahoma City, United StatesX4 Life Sciences are working with a cutting-edge biologics manufacturer in the oncology and autoimmune disease space, who are looking to bring on board a Regulatory Affairs CMC Manager / Senior Manager to support global regulatory submission projects and be hands-on in the prepar ...
-
Associate Director Regulatory Affairs Ad Promo
3 weeks ago
EPM Scientific Oklahoma City, United StatesTitle: · Associate Director, Regulatory Affairs Advertising & Promotion · The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications ...
-
ACIP Oklahoma City, United StatesNanobiotix – a brief history · Est. 2003, Nanobiotix is a clinical-stage biotechnology company focused on developing first-in- · class product candidates that use proprietary nanotechnology to transform cancer treatment. · Headquartered in Paris (c.70 staff) and with a US affilia ...
-
Regulatory Affiars Lead
2 days ago
Inceed Oklahoma City, United StatesCompensation: $90,000 - $140,000 · Location: Oklahoma City, Oklahoma · Regulatory Affairs Lead: · Inceed has partnered with a great company to help find a skilled Regulatory Affairs Lead to join their team · Responsibilities:Track and assess regulations at the federal, state, ...
-
Executive Director, Medical Affairs
3 weeks ago
Morphic Therapeutic Oklahoma City, United StatesAbout Morphic Therapeutic · Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration ...
-
Product Security Engineer
1 week ago
Motion Recruitment Partners LLC Oklahoma City, United StatesProduct Security Engineer · Position Overview: · We are looking for a skilled and motivated Medical Device Product Security Engineer to play a key role in securing our medical device products throughout their lifecycle. The successful candidate will work closely with cross-functi ...
-
Director/Senior Director Regulatory CMC
4 days ago
EPM Scientific Oklahoma City, United StatesThe client is dedicated to developing innovative therapies to address unmet medical needs. We are focused on advancing our clinical pipeline through key regulatory milestones. As a nimble and dynamic organization, we offer a collaborative environment where your expertise will dir ...
-
Senior Oncology Regulatory Specialist
4 days ago
University of Oklahoma Oklahoma City, United StatesJob Description - *Senior Oncology Regulatory Specialist · *Senior Oncology Regulatory Specialist · - · Job Number: · 241388 · Organization · Job Location · Schedule · Schedule · : · Full-time · Work Schedule · : · Monday-Friday 8am-5pm · Work Type · : · Onsite · Sal ...
-
Sr. MSL II, Glaucoma and Retina
1 week ago
BioSpace Oklahoma City, United StatesJob Details · Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key the ...
-
Director of Quality
3 weeks ago
Molecular Search Oklahoma City, United StatesMolecular Search is proud to collaborate with a premier CDMO specializing in drug product development and manufacturing. Our client is dedicated to delivering high-quality pharmaceutical solutions to enhance patient health and well-being. · Responsibilities: · Lead the developme ...
Senior Director/Director, Global Regulatory Affairs - Oklahoma City, United States - Corbus Pharmaceuticals
Description
Senior Director/Director, Global Regulatory AffairsFull-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 what's 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 TGFβ 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, 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.
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.
#J-18808-Ljbffr
