Regulatory Affairs Manager
- Employer
- i-Pharm Consulting
- Location
- Homeworking
- Salary
- GBP55.0 - GBP58.19 per hour
- Start date
- 24 May 2023
- Closing date
- 21 Jun 2023
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Regulatory Affairs Manager
12 month contract
EU Oncology
£58.19 per hour - inside IR35
UK - home based
Responsibilities:
- Advising EU regulatory considerations in developing strategy.
- Planning and managing regulatory submissions (CTA's and MAA's) for products within our client's portfolio.
- Leading development of EU regulatory documents and meetings.
- Providing regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans).
- Act as point of contact with the EMA.
Knowledge and Skills:
- 4+ years of EU Regulatory Affairs experience concerning the EU region including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
- Good knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Experience with RTQ's with EMA.
Please note this role sits outside of regulatory CMC, so CMC experience is not relevant.
To apply for this role you must be based in the UK and have the right to work in the UK.
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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