Vacancy caducado!
Our client, a leading Pharmaceutical Company is hiring a Regulatory and Medical Affairs Specialist on a contracting basis.Location: Summit NJ (remote until restrictions are lifted)Job Description: Regulatory CMC - BiologicsTypical Daily Work Hours = Mon-Fri, 40 Hrs/Wk, 8am to 5pm (some flexibility in daily start/end times)Weekend & OT work = None expected.Work Location: Initially worker will work from home, but after COVID crisis, the position is intended to be 100% onsite work at Summit NJ. Not interested in candidates that only want to work remotely all the time.CONSULTANT, GLOBAL REGULATORY CMC CELL THERAPYClient is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to Client and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique cultureThe Consultant will be based in Summit, NJ and will assist the Regulatory-CMC Cell Therapy team with projects to support department goals and objectives. Job Responsibilities require the following skills: Attention to detail, excellent organization skills, good verbal and written communication skills are required. Ability to work independently on routine assignments with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment. Computer experience must include familiarity with Word, Excel and PowerPointJob Duties" Support Regulatory CMC Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global cell therapy applications.Qualifications" Must have 5-7years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Biologic / Cell Therapy Regulatory CMC experience, including the preparation of Biologic / Cell Therapy CMC dossiers" At least a bachelor s degree required.Skills/Knowledge Required:" REQUIRED: Experience with Biologic / Cell Therapy CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)" REQUIRED: Experience with CMC regulations for biological / cell therapy compounds" A PLUS: Experience with Gene/Cell/CAR T Cell therapy CMC regulations" REQUIRED: Practical knowledge of FDA, EMEA, Canadian and ICH guidelines." A PLUS: Practical knowledge of rest of world post approval guidelines" REQUIRED: Have a solution-oriented approach to problem solving" A PLUS: Expertise in the biologic / cell therapy drug development process and post approval activities" REQUIRED: Ability to work on complex projects and within cross-functional teamsPlease contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested.Regards,Devan PatelTechnical Recruiter
Vacancy caducado!