23 Mar 2021 Senior Regulatory Affairs Specialist · Regulatory Affairs Specailist · Regulatory Associate - Level 1 · Regulatory Affairs (Clinical) · Regulatory

As a Principal Regulatory Affairs Specialist for Chemistry, Manufacture and Controls (CMC) - lead focus on Advanced Therapies, you will provide innovative regulatory solutions to our clients. The purpose of this role is to lead and support Global Regulatory CMC projects across multiple product types with a lead focus on Advanced Therapies (Cell and Gene therapies).

Advanced degree preferred, such as PhD, MD or JD. Other Job Requirements ~15-20% national and international travel anticipated. WHAT TAKEDA CAN OFFER YOU: Search Cmc regulatory jobs in Durham, NC with company ratings & salaries. 6 open jobs for Cmc regulatory in Durham. Regulatory Affairs is one such area that we always like to pipeline because of the high demand at the same time niche domain that it is.

Job Description You will be CMC Regulatory Affairs responsible for one or more commercial and/or development small molecule compounds for all markets worldwide. Responsibilities. You will actively participate in several development and other teams; Regulatory CMC jobs in the USA All New Filter 1,391 jobs Create alert All New Senior Manager, Global Regulatory Affairs CMC Submissions Management Save. Takeda. Cambridge, MA By clicking the “Apply” button, I understand that my Plan, write and review DMFs and CMC sections for INDs, CTAs, NDAs, BLAs, amendments, and life-cycle management submissions. Conduct post-approval CMC regulatory activities such as change controls, etc. Provide regulatory support and advice for internal and external customers in line with defined regulatory plans and in response to ad-hoc questions.

Novartis AG. Heltid | Regulatory Affairs CMC Manager - Cell. Search Protein jobs in Sweden with company ratings & salaries.

Maintain CMC related submission information in the relevant systems, track regulatory com-mitments and timelines for specific projects/products/markets. With minimal supervision, plan, author and manage the assembly and timely submission of CMC related sections of IMPDs, INDs, NDAs, MAAs, post approval, renewal, line extensions and other dossiers to meet filing requirements.

Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Posted 4 weeks ago. The PositionThe Director, Regulatory Affairs CMC, is responsible for developing, leading, and…See this and similar jobs on LinkedIn. Job Description.

Ascelia pharma: storägaren cmc — Jämför Ascelia Pharma Nextcell pharma aktie Hoppa till Director Regulatory Affairs på Ascelia Pharma AB.

Indeed may be compensated by these employers, helping keep Indeed free for jobseekers. Indeed ranks Job Ads based on a combination of employer bids and relevance, such as your search terms and other activity on Indeed. 1,928 regulatory cmc jobs available. See salaries, compare reviews, easily apply, and get hired. New regulatory cmc careers are added daily on SimplyHired.com. The low-stress way to find your next regulatory cmc job opportunity is on SimplyHired. There are over 1,928 regulatory cmc … To find out more about how Regulatory Professionals can assist with your regulatory CMC job search, contact us on +44(0)118 952 2797 or email us at apply@regulatoryprofessionals.com.

ROLE SUMMARY Experienced CMC professional serving as project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting the Pfizer Biopharmaceuticals Group Hospital Category Business Unit, specifically Anti-Infectives, independently or with minimal supervision. have finished the other sections of the document.
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- Provide regulatory CMC advice to project members. - Lead preparation of We are pleased to offer this new role of Regulatory Affairs (CMC) Manager, Pharmaceuticals . Click here to view and apply today.

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Regulatory Affairs Manager – CMC 12 month contract. The opportunity to work with a leading Life Sciences Consultancy who works with 19 out of 25 of the top Life Sciences companies has become available! My Client is urgently seeking an experienced CMC Regulatory Affairs professional to work with them on a remote basis 5 days per week.

Job Description Summary: The Senior Manager, Regulatory Affairs – CMC will play a key role in supporting regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC… and other PTC departments under supervision of the Regulatory Affairs – CMC management. … 64 head regulatory cmc biologics jobs available. See salaries, compare reviews, easily apply, and get hired.

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Experience in authoring pharmaceutical development related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions. • Excellent communication

See salaries, compare reviews, easily apply, and get hired. New regulatory cmc careers are added daily on SimplyHired.com. The low-stress way to find your next regulatory cmc job opportunity is on SimplyHired. There are over 1,928 regulatory cmc … To find out more about how Regulatory Professionals can assist with your regulatory CMC job search, contact us on +44(0)118 952 2797 or email us at apply@regulatoryprofessionals.com. Alternatively, you can check our ‘Vacancies’ page for the current Regulatory CMC Jobs . What are employers looking for when you apply for regulatory CMC jobs? Those looking to progress their pharmaceutical regulatory affairs career within CMC and wish to move from a junior collating/coordination role, such as regulatory executive, to a more senior regulatory role, may want to consider ways in which they can expand their CMC skill set.

2,326 Cmc Regulatory jobs available on Indeed.com. Apply to Regulatory Affairs Manager, Senior Manager, Regulatory Project Manager and more!

Tycker du att arbetsgivaren eller yrket är intressant, så kan Rolf Eriksson har börjat som expert inom Regulatory och CMC på Arex Advisor. Han har en doktorsexamen i Sandra Eketorp Sylvan är ny medicinsk chef vid Experience in authoring pharmaceutical development related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions. • Excellent communication Find the perfect job for your talent. Job Search.

What are employers looking for when you apply for regulatory CMC jobs? Those looking to progress their pharmaceutical regulatory affairs career within CMC and wish to move from a junior collating/coordination role, such as regulatory executive, to a more senior regulatory role, may want to consider ways in which they can expand their CMC skill set.