Skip to main content

This job has expired

Regulatory Affairs Assistant

Employer
i-Pharm Consulting
Location
Cambridge, Cambridgeshire, England
Salary
Negotiable
Start date
21 Sep 2021
Closing date
5 Oct 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Entry level

Job Details

Reg Affairs Assistant

12 month contract

This role will be based in Cambridge - ideally full-time office based or may consider 3/4 days in office for experienced candidate.

£20.30 per hour

We have a 12 month contract opportunity for an Assistant, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls), to provide administrative support in the preparation of Chemistry and Pharmacy dossiers for submission to worldwide Regulatory agencies, for the licensing of new medicinal products and continued maintenance of product licenses.

RESPONSIBILITIES

  • Preparation and collation of administrative documents required for submission to regulatory authorities.
  • Performs document filing and retrieval and organizes regulatory documentation within company systems.
  • Arranges translation of dossier content by external vendors into the appropriate language for submission to worldwide authorities.
  • Works with colleagues in Manufacturing, Development and Quality Assurance functions to collate manufacturing site documents, SOPs and reports in support of manufacturing site licenses and GMP certification applications.
  • May aid with preparation of Microsoft Word documents, Excel spreadsheets and PowerPoint presentations.
  • Contributes to local administrative process improvements within Regulatory Affairs CMC.
  • Works to acquire and develop regulatory skills and knowledge under guidance from supervisor.

KNOWLEDGE, EXPERIENCE AND SKILLS

  • Good organizational skills and attention to detail, and the ability to work on a number of projects in alignment with defined timelines.
  • Good verbal and written communication skills and interpersonal skills.
  • Ability to work in adherence to defined procedures and standards in a regulated environment.
  • Keenness to develop an understanding of Regulatory Affairs and product licensing requirements across a range of diverse markets.
  • BA/BS or equivalent education in a relevant subject preferred.

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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert