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Regulatory Affairs Manager

Employer
i-Pharm Consulting
Location
Homeworking
Salary
GBP50000.00 - GBP58000.00 per annum
Start date
5 Aug 2022
Closing date
19 Aug 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

Regulatory Affairs Manager

Leading Cell and Gene Therapy company

Permanent opportunity

Home based in the UK

Maximum salary of £58,000 per annum with benefits

The Key Purpose of the role is to:

  • Implement optimal regulatory strategies for each programme
  • Compile and submit regulatory submissions
  • To support the development programmes in place

Key Accountabilities:

  • Develop an agreed regulatory strategy and implementation plan for each programme
  • Prepare regulatory documents (briefing documents, GMO submissions, CTAs, INDs, amendments, safety reports, annual reports, etc.
  • Develop and maintain constructive working relationships with regulatory agency and health authority contacts.

Experience:

  • Approximately 3-5 years' or more regulatory affairs experience, ideally with 1-2 years in a cell and/or gene therapy environment or, at a minimum, with some experience in the regulation of biologic or biotech products
  • Proven experience of working independently in the drafting and delivery of high quality regulatory documents

Knowledge / Skills / Competencies:

  • Proven ability to evaluate and implement efficient regulatory strategies
  • Ability to lead the quality and regulatory aspects of the development strategy for assigned Programmes
  • Demonstrable regulatory leadership of CTA /IND processes as well as experience of scientific advice meetings with Regulatory Authorities is an advantage

In addition, one or a combination of the following are also highly desirable

  • Experience of registration of cell and gene therapies for clinical trial throughout the EU/UK and US
  • Experience of EU centralised procedures such as ATMP classification, paediatric investigational plans and orphan drug applications
  • Knowledge of US, Japanese, Canadian or Chinese regulatory frameworks
  • Working knowledge of EU GMP and tissues and cells legislation

Education / Qualifications:

  • Higher degree or at a minimum graduate in a life science subject.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, Los Angeles and San Diego. In a highly competitive market-place, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

Find Us
Website
Telephone
+44 (0) 20 3189 2299
Location
22 Long Acre
London
England
WC2E 9LY
United Kingdom
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