The Manager, Regulatory Affairs (CMC) will lead in the planning, preparation and review of investigational new drugs applications (INDs), Clinical Trial Applications, new drug applications (NDAs), market authorization application (MAA) and all related annual reports, DMFs, amendments, supplements as well as their ongoing maintenance. The Manager will also lead the preparation and review of regulatory submissions (CMC sections) as well as CMC related responses and inquiries from regulatory agencies. We are seeking a talented Manager to help develop (CMC) regulatory strategies and provide (CMC) regulatory guidance to cross-functional teams and key stakeholders while acting as the primary regulatory (CMC) contact for ongoing projects and responsibilities.
This is a newly created position based on growth
Lead the preparation and review (of CMC sections) of relevant regulatory submissions, as well as the interactions and responses with regulatory agencies
Develop global CMC regulatory strategies for one or more investigational and marketed products
Collaborate with US & International regulatory colleagues in development of global CMC regulatory strategies and submissions
Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Work effectively on cross-functional teams and be the primary regulatory CMC contact for assigned products and projects
Become a key resource for relevant personnel to provide regulatory advice to help guide CMC development activities
SKILLS & REQUIREMENTS:
Bachelor's Degree required, Advanced Degree preferred in appropriate field with 5+ years Regulatory experience in biotech or pharmaceutical industry
Regulatory affairs (CMC) experience (or relevant experience), preferably in Phase 3 studies
Solid understanding of full drug development process
Thorough understanding of U.S. and Euro regulatory requirements and the operating characteristics or regulatory agencies
Experience in developing or assisting the regulatory strategy of all stages of drug development from IND to market approval
Familiarity with accelerated regulatory pathways a plus
RAPS certification a plus
Ability to identify and remedy key regulatory issues and to anticipate potential regulatory hurdles
Energetic, positive team player
Corbus is a close-knit team of almost 100 employees who are high-achievers,innovative, creative and, above all else, passionate about what we do. We hirefor personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where youwill succeed based on your contribution and work ethic, not on your title orrank. At Corbus we take pride in our "family" atmosphere where each person'scontribution is vital to our success. As a Corbus employee, you are empoweredto think creatively and be proactive in your approach. There is no place forpolitics or red tape here. Positive, team-oriented people work at Corbus andare rewarded with fun perks like weekly food deliveries to our kitchen, amonthly in-house massage therapist, company-paid classes with Title Boxing, andorganized company activities and outings. Additionally, Corbus offers anattractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3clinical-stage pharmaceutical company focused on the development andcommercialization of novel therapeutics to treat inflammatory and fibroticdiseases by leveraging its industry leading pipeline of endocannabinoidsystem-targeting drug candidates. The Company's lead product candidate,Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2(CB2) agonist designed to resolve chronic inflammation and fibrotic processes.Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis,dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture andmarket drug candidates from more than 600 novel compounds targeting the endocannabinoidsystem from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2ndgeneration, peripherally-restricted, selective cannabinoid receptor type 1(CB1) inverse agonist specifically designed to eliminate blood-brain barrierpenetration and brain CB1 receptor occupancy that mediate the neuropsychiatricissues associated with first-generation CB1 inverse agonists. Potentialindications for CRB-4001 include NASH, primary biliary cholangitis, idiopathicpulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosisafter myocardial infarction and acute interstitial nephritis, among others.CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a NationalInstitutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer
Corbus Pharmaceuticals Holdings, Inc.