Senior Regulatory Affairs Manager job in London, England

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Last Name*

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Phone Number*

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Job type: Permanent

Discipline: Operations

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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.

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Highly Competitive Salary

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Philadelphia, USA

Proclinical Staffing is seeking an Associate Director of Regulatory Affairs to join a top medical program.

Natalie Magola

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Senior Director, Regulatory Affairs - REMOTE

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Up to US$290000 per annum + Highly Competitive Salary

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Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization.