Skip to main content

This job has expired

Senior Regulatory Operations Associate

Employer
i-Pharm Consulting
Location
Homeworking
Salary
Negotiable
Start date
4 May 2021
Closing date
18 May 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Senior Regulatory Operations Associate - Submission Management - 30696

12 month contract - 37.5 hours per week

£32.22 per hour maximum pay

Office base preference in Cambridge - flexibility to be afforded

Highly innovative Biopharmaceutical company

Description

The Senior Associate is an experienced Regulatory Operations professional responsible for facilitating product development and global registration through the efficient preparation, management and tracking of regulatory documentation and submissions.

Reporting to Sr Manager, Operations, the core elements of this key role will include leadership of key filings in Europe and the Extended EU Markets including compilation, publishing and QC of submission dossiers for clinical trials, paediatrics and marketing applications. You will also have the opportunity to work as part of the global team on Marketing Applications for new products, so collaborative working will be paramount to your success in this role.

This is a fantastic opportunity to join a high performing European team in an organisation focused on talent development.

Responsibilities include:

  • Work as part of a global Regulatory Operations team, contributing to global filings
  • Lead key submissions for EU, Switzerland and Emerging Markets
  • Compilation and publishing of submission dossiers for Europe and the extended EU markets for clinical trials, paediatrics and marketing applications according to regional regulatory agency guidance
  • Work closely with submission content providers to advise on submission content, structure, planning and strategy
  • Submission management of publishing tasks sent to publishing vendors
  • Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations
  • Document management of ongoing submissions, e.g. building dossier structure, sourcing documents
  • Quality control of submission ready components and submission dossiers
  • Preparation, dispatch and tracking of electronic and paper media
  • Maintenance of submission information in Regulatory Registration Tracking system

Minimum requirements:

  • Degree or equivalent combination of experience and knowledge
  • Minimum of 3-4 years of demonstrated regulatory publishing experience within the pharmaceutical industry
  • Advanced knowledge of MS word and Adobe Acrobat
  • Use of specialist publishing software to prepare submissions - Insight Publisher preferred
  • Use of electronic document management systems
  • Understanding of Regulatory submission requirements

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