Regulatory Affairs Publisher

2019-11-27 12:00:132020-01-10LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 35,000 ~ 38,000 Competitive
Job Ref0064I0000103Ls7QAE
Job Views526
Description

Regulatory Publisher

The successful candidate will be responsible for the daily operational activities for regulatory submissions and archives in accordance with agency requirements and company standards.

 

Location: Hertfordshire (home working also available)

Salary: Competitive + benefits & bonus


ESSENTIAL FUNCTIONS

 

The Regulatory Publisher is responsible for planning, electronically formatting and compiling regulatory submissions to achieve client deliverables and ensure quality, accuracy, and submission readiness. This includes:

 

-         Applying full hyperlinking and bookmarking, performing quality control checking and being responsible for troubleshooting any publishing related activities and performing document level publishing tasks.

-         Ensuring consistency, completeness and adherence in accordance with Regulatory agency guidance and specifications, whilst also complying with internal procedures.

-         Providing guidance on good documentation and lifecycle management.

-         The ability to manage and prioritize multiple tasks in a fast-paced environment whilst maintaining submission timelines.

-         Staying current with new eCTD guidance and Global Health Authorities Submission Requirements.

-         Preparing and formatting a variety of routine and non-routine Word and PDF documents

-         Collaborating with project managers/leads to discuss preparation and submission timelines

 

KNOWLEDGE AND ABILITIES

               

-         Bachelor’s Degree or commensurate experience

-         Minimum of 1-2 years’ experience with electronic regulatory submission, associated publishing tools, templates.

-         Strong technical aptitude, preferably with extensive exposure to Microsoft Word, Adobe Acrobat and the use of DXC Toolbox (ISI Toolbox)

-         Knowledge of the regulations and processes that govern content, maintenance and submission of controlled documents required by regulatory authorities.

-         Excellent communication skills, both verbal and written.

-         Exceptional attention to detail as well as organizational skills, including the ability to prioritize and multitask.


For further information please get in touch with Natalie Jones via natalie@linkfieldgroup.com or call 02071835059

Apply Later
Sign in
Register
Apply
Later
Register with
Natalie Hopkins
Recruitment Director
Browse Natalie's jobs
View Natalie's bio
Get in touch with Natalie
0207 183 5059
Similar Jobs
  • 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...

  • Senior Quality Assurance Manager - Biotechnology Company - Oxfor
    UK, London, M4 Corridor
    Pharma / Biotech
    £ 60,000 ~ 70,000 Competitive

    We are currently partnering with a clinical-stage Biotechnology company based in Oxford who are looking for a Senior Quality Manager. The main purpose of the role is to ensure the highest quality standards are in place and embedded within the organisation and are adhered to at all times. The role...

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