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Senior Regulatory Affairs Manager

Description

A popular hospital in search of an experienced Regulatory Affairs Manager to provide operational support. The London based role will focus on clinical trials and manufacturing initiatives. Job Responsibilities: To liaise closely with relevant departments across CGT Catapult and external Collaborators to ensure proposed developments (manufacturing and analytical) are fit for purpose and suitably planned whilst ensuring the development programme will meet regulatory and quality requirements With the Head of Regulatory Affairs, develop an agreed regulatory strategy and implementation plan for each programme Maintain up to date knowledge of development in regulations, CMC and GMP requirements for ATMPs Author and compile regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards Ensure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals Develop and maintain constructive working relationships with Competent Authority and Health Authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management Line management of more junior members of the team including delegation of key activities Skills and Experience: Graduate in a life science subject as a minimum, post graduate degree desirable Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products including orphan indications Keeps up to date with professional knowledge, expertise and best practice. Excellent oral and written communication skills. To Apply Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies. Apply for Senior Regulatory Affairs Manager Already uploaded your CV? Sign in to apply instantly Apply First name Required Last name Required Email address Required Upload your CV Required Upload from your computerOr import from cloud storage Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB Your covering message for Senior Regulatory Affairs Manager 4000 characters left Add my CV to PharmiWeb's CV database, and let the jobs come to me! Email me jobs like this one when they become available Please email me a free CV review from Marketing Communication We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email. Yes please. I'd like to receive emails about jobs and services from PharmiWeb.jobs I'd like to receive emails from third parties All emails will contain a link in the footer to enable you to unsubscribe at any time. When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us . PharmiWeb.com is Europe’s leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings. The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.

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London, England, London, SW1V, United Kingdom

  • Ad ID:  16887294
  • Ad Type:  Offered
  • Posted on:  18/11/2020, 03:53
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