Regulatory Affairs Manager UK & Ireland - part time (3 days per

2019-10-14 16:00:152020-02-19LinkField Life Sciences
Job TypeContract
AreaCentral London, UK
SectorPharma / Biotech
Salary£ 50 ~ 70 Hourly Rate
Job Ref0064I00000yaVdYQAU
Job Views1307
Description

We are currently working with a Specialist Pharma company with a global presence.


Role:

This is a role involves heading up Regulatory Affairs activities for the UK / Ireland Affiliate for 3 days a week. The role acts as a local safety representative for Pharmacovigilance purposes.


Location:

The position is based in their London office with the flexibility for 1 day of home working if desired  

 

Responsibilities:


Regulatory:

·        Ensure regulatory submission (National applications) is completed in a timely manner & ensure the companies interests are aligned to and represented by the Global Regulatory Affairs teams. 

·        Perform routine regulatory activities i.e. maintenance/renewals, variations, 61(3) notifications.

·        Provide technical input where required

·        Ensure artworks are created and approved in time for product launches

·        Maintain current knowledge of regulatory affairs legislation

·        Ensure all regulatory databases are kept up to date

·        Provide support for marketing material

·        Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues


Safety contact (Pharmacovigilance), experience preferred not essential:

·        Ensure pharmacovigilance activities performed are completed in a timely manner, and in accordance with pharmacovigilance legislation, acting as deputy (back‐up) to compliance manager.

·        Ensure PSUR's are submitted in accordance with agreed schedules.

·        Maintain effective dialogue with pharmacovigilance contract providers acting as deputy (back‐ up) to compliance manager.

·        Ensure regulatory changes to product information are provided in a timely manner to the pharmacovigilance contract provider and all relevant departments acting as deputy (back‐up) to compliance manager.


Quality Assurance, experience preferred not essential:

·        Prepare and maintain Product Compliance Files

·        Review of validation documents

·        Ensure Quality systems are maintained

·        Ensure retained samples are stored in accordance with SOP

·        Prepare/review SOP's where required

 

For further information please get in touch with Natalie Jones on 0207 183 5059 / natalie@linkfieldgroup.com

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
  • 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