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Senior Regulatory Affairs Manager, London

Published 2022-05-14
Expires 2022-06-14
ID #996238234
Free
Senior Regulatory Affairs Manager, London
United Kingdom, London, London,
Published May 14, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Senior regulatory affairs manager


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Description

*SENIOR REGULATORY AFFAIRS MANAGER*RApport is currently searching for a Senior Regulatory Affairs Manager to join their friendly and dynamic team. You will ideally have considerable regulatory experience and have a strong understanding of life cycle management of medicinal products including authoring documents.The position will require developing, leading and implementing global regulatory strategies for product lifecycle. You will be familiar with all phases of development to post-approval, to advise on strategies through the product lifecycle.RESPONSIBILITIESYou will lead discussions with clients to ensure their requirements are met as far as possible.* Developing risk registers for regulatory submissions (BLAs/NDAs, MAAs, INDs, CTAs) and outlining regulatory risks Leading prep meetings before direct interaction with Health Authorities. (e.g. EMA, FDA) Providing regulatory impact assessments Maintaining current and emerging knowledge on regulatory requirements and communicate them with colleagues Creating, maintaining and continually evaluating/improving Regulatory processes, policies, and systemsDESIRABLE EXPERIENCEDirecting project activities for multiple complex projects and teams simultaneously, as appropriate.Providing strategic direction, data assessment and conclusions within and across departments.Developing strategies and recommending the appropriate regulatory actions e.g. reporting mechanism.Working with cross-functional project teams including suppliers and contract manufacturers as required, to ensure alignment of development and implementation of activities with overall regulatory strategies.Managing post approval change controls, liaising with stakeholders to ensure regulatory compliance.CMC (Module 3 and other relevant CMC sections i.e. Module 2.3) authoring regulatory experience in post approval submissions of e.g. pharmaceuticals/ biologics/ biosimilars/ consumer health/ medical devices for EU, US, JP, and other global markets.Understanding, interpreting, and advising on regulations, guidelines, procedures, and policies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global applications.ABOUT YOUExtensive regulatory affairs experience in the pharmaceutical industry including managing product lifecycle. Your experience will ideally include experience in regulatory consultancy.You will be a hard-working person who enjoys working in a very collaborative and supportive environment.You will be happy to work directly with clients as a key contact delivering projects on time as agreed with the client.You will be able to work both independently and with others in the team including our highly skilled subject matter experts.You will have a track record of successful authoring and contributing to delivering sections of marketing authorizations.This great opportunity needs someone to come aboard and develop and implement regulatory strategies to meet our clients' milestones.You will receive a competitive salary, the opportunity to develop your skills in an exciting and varied role and work with an ambitious, flexible and highly rewarding company.The role can be home or office based depending on the candidate. While full time is preferred, flexible working can be arranged for the right candidate.QUALIFICATIONSBSc/ MSc/PhD degree in Pharmacy, or other suitable life sciences-related subjectExperience with LCM, writing regulatory documentation and European and US Regulatory proceduresExperience with biological products or cell and gene therapy would be ideal but not essential

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    Employer's info

    Rapport Global Strategic Services Ltd
    Registered on October 7, 2017

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    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.


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