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.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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