Regulatory Operations and Systems Manager


This job does not exist anymore.

Try running a new searchor browse our vacancies.

Or fill in the form below to receive job alerts.

2019-09-04 20:00:121970-01-01LinkField Life Sciences
Job TypePermanent
AreaGreater London, UK
SectorPharma / Biotech
Salary£ 55,000 ~ 65,000 Annual Rate
Job Ref0064I00000xKMozQAG
Job Views701
Description

The appointed Regulatory Operations and System manager will make proposals for appropriate software solutions and systems to support business processes including publishing and electronic filings to key authorities and archiving. The chosen candidate will be responsible for the maintenance of software. Responsibility will include the planning, creation and despatch of high-quality CTD and eCTD dossiers, training authors on and assisting them with source document formatting. Currently the function manages regulatory affairs’ archiving, SOPs and regulatory information (RIM) and IDMP conform data bases.


Responsibilities will include:

  • Confirming compliance of paper, NeeS and electronic dossiers with health authority requirements worldwide with the aim to be fully electronic wherever and whenever possible
  • Appropriate publishing and dispatch of paper, NeeS and electronic dossiers to health authorities worldwide               
  • Identifying system requirements as well as defining and delivering well-suited solutions that meet the needs of authors regarding the preparation and management of source documents, the planning and tracking of submissions, the viewing and archiving of dossiers
  • Generating and maintaining SOPs and manuals for the RA department as required
  • Maintaining and evolving electronic publishing systems for paper and electronic dossiers
  • Maintaining appropriate and compliant archiving solutions for the RA department.
  • Implementing new regulatory affairs systems, tools and data bases (e.g. regulatory information management, document management)
  • Managing third party vendors of systems and services
  • Manages permanent and temporary staff in the function

·        

Salary: Competitive + Package


For further information please get in touch with our lead consultant Natalie Jones on 0207 183 5059 or email your details directly to natalie@linkfieldgroup.com

Keywords
SectorClear
AreaClear
Job TypeClear
Sign in
Register
Natalie Hopkins
Recruitment Director
Browse Natalie's jobs
View Natalie's bio
Get in touch with Natalie
0207 183 5059
Similar Jobs
  • Regulatory Associate Director - EU Established Products
    UK, London, Central London
    Pharma / Biotech
    £ 70,000 ~ 80,000 Competitive

    Working as part of an evolving Regulatory group, this EU leadership role will combine hands on technical project work and team management. You will provide a regulatory strategic focus for lifecycle management including variations / amendments, renewals, line extensions / MAAs.


    ...

  • Global Regulatory Lead - 8 month contract - £70 per hour
    UK, London, Central London
    Pharma / Biotech
    £ 60 ~ 70 Hourly Rate

    We are currently partnering with a Global pharma company who are looking for a Global Regulatory Lead to work on their Established products portfolio covering Global Markets.


    This 8 month contract will involve undertaking a range of post marketing activities across Global regions...

  • Senior Regulatory Manager / Associate Director - Oncology - Biot
    UK, London, West London
    Pharma / Biotech
    £ 70,000 ~ 80,000 Competitive

    We are currently partnering with an Oncology Biopharmaceutical company who are developing novel cancer immunotherapies (previous ATMP / Cell Therapy experience is NOT a prerequisite for this position although would be an added bonus). 


    We are looking for an experienced Regulator...

Email Me Jobs Like This
Subscribed to similar jobs notifications

To find out more about Linkfield Life Sciences Ltd, and how we can partner with you to support your Regulatory Affairs recruitment requirements, please contact us below:

WE’RE EASY TO FIND

Office 2b
Mercury House,
High Street,
Tattenhall, TN8 6EN

  • 0207 183 5059
  • info@linkfieldgroup.com
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
+Necessary
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
essential
SessionUsed to track your user session on our website.
essential

More Details