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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

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, and Los Angeles. In a highly competitive marketplace, 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.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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