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Regulatory Affairs Manager

Employer
i-Pharm Consulting
Location
England
Salary
GBP50.00 - GBP58.19 per hour
Start date
21 Sep 2022
Closing date
5 Oct 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Job Details

31872 - Regulatory Affairs Manager

£58.19ph

UK home based / Uxbridge

6 month contract

37.5 hours per week

Description

This role will support one or more products from a regional regulatory perspective.

  • Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products.
  • Interfaces with the client's affiliate offices for specific strategies or activities that impact a specific country.
  • Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
  • Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
  • Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within our client's portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
  • Authoring and coordinating responses to questions across assigned products and countries.
  • Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
  • Provides guidance for regulatory assessments of change control requests

Requirements

  • 4+ years of CMC Regulatory Affairs experience concerning biologics products
  • Ability to demonstrate working independently
  • Strong communication skills

Please note - applicants from outside the UK will not be considered. You must have the right to work in the UK upon application 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.

 

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

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