Regulatory Affairs Senior Manager
- Employer
- i-Pharm Consulting
- Location
- England
- Salary
- Negotiable
- Start date
- 21 Sep 2022
- Closing date
- 5 Oct 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Senior Management
Job Details
Regulatory Affairs Senior Manager
UK - home based
12 month contract
37.5 hours per week
Competitive pay rate
Description
- May manage one or more regional leads or support roles Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications)
- Leads development of regional regulatory documents and meetings in accordance with strategy
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan)
- Agency interaction
Knowledge and Skills
- 7+ years of experience in Regulatory Affairs concerning CTAs, MAs, post approval changes, extensions and renewals.
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Experience with Oncology products in Regulatory Affairs
Applicants must be based in the UK already to be considered for this role
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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