Regulatory Affairs Manager

Employer
Volt
Location
Hertfordshire, England, GB
Salary
Competitive
Closing date
19 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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Role and Responsibilities:

*Support global regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational, and provide input into relevant sections of development plans for assigned programmes.
*Support the Global Regulatory Companion Diagnostics (CDx) Lead to implement a successful co-development strategy that bridges across the assigned gene therapy(ies) and companion diagnostic(s).
*Ensuring preparation and submission of high-quality regulatory documents including, but not limited to, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance.
*Act as contact point for internal and external clients, including CROs and regulatory authority interactions.
*Responsible for the regulatory project management for assigned projects i.e. planning and tracking submission and approval timelines, regulatory commitments, etc.
*Contribute to the growth of the Function, including supporting GxP compliance and inspections and regulatory systems.
*Remain expert and up to date on global regulatory requirements including nonclinical and clinical aspects.
*Keep abreast of relevant regulatory intelligence and ensuring this is communicated, appropriately, across the Company.
*Assist with training of staff in regulatory matters as required.

Requirements
*Relevant degree in a life science / science discipline.
*At least 6-8 years' experience in regulatory affairs across various companies preferably in biotechnology/biologicals and/or rare diseases in a centralized European setting where US experience would be a bonus.
*Knowledge and understanding of EU and ICH guidelines and experience of working to GxP is essential. Awareness of US and Canada guidelines and understanding of the in vitro device/companion diagnostic regulations would be a bonus.
*Experience in the preparation of regulatory submissions during the lifecycle particularly INDs/CTAs, scientific advice briefing documents, PIPs and/or orphan designation applications or sections of the MAAs/NDAs and/or post-approval submissions.
*Interactions with the EMA and European national regulatory authorities required; any experience with FDA interactions would be a bonus.
*Demonstrated ability to create and drive an effective regulatory strategy and handle critical issues effectively with demonstrated creativity in solving regulatory issues.

Apply now

Volt’s European business is wholly owned by Volt Information Sciences, Inc. a global company with operations in over 110 offices covering Europe, the Americas and Asia. Generating annual revenues in excess of $1.5 billion, the company delivers best in class Talent, Technology and Consulting services to its customers.

Volt first traded in Europe in 1978, initially delivering temporary and permanent IT recruitment solutions to clients in the UK. The company has since enjoyed significant growth in both the range and geographical scope of its services, and now has European bases in Belgium, France and the UK, delivering: 

Life Sciences

Engineering

Professional Services

IT

Contact Us
  • Volt House
  • 3 Chapel Road
  • Redhill
  • RH1 1QD
  • GB
  • +44 1737 774100
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