Global Regulatory Submission Publisher

Employer
Xplore Pharma
Location
Basel
Salary
Not specified
Start date
23 Nov 2022
Closing date
23 Dec 2022

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Job Details

This is an exciting contract opportunity in Basel for a top 10 Pharmaceutical company who seek a Global Regulatory Submission Publisher.

This role can offer some remote working.
  • The role:
  • Responsible for electronically preparing, publishing, quality reviews, and validation activities related to regulatory submissions
  • Produce high quality, HA compliant submission
  • Partners with Operations Submission Managers and a publishing team Comply with and actively apply internal work practices and guidelines.
  • Support implementation of new technologies, tools and processes.
  • Identify process or technical issues and propose solutions 
Requirements:
  • 5-8 years submission publishing experience in Pharma or related industry  Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
  • Effective interpersonal skills, strong written and oral communication and presentation skills.
  • Project management and time management skills to manage multiple ongoing projects simultaneously. 
  • Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
  • Working knowledge of regulatory affairs

Company

Xplore Life Science is a Life Science and Pharmaceutical Recruitment Consultancy providing an expert service, we are a challenger life science search firm. We place specialist talent within pharma, medical device, medical technology and consultancy businesses in the UK, Benelux, Switzerland (SECO License), Germany and the USA. Delivering on a contract, interim, permanent and retained search basis through a client-centric, transparent and lean recruitment process. Xplore are fully invested in our clients and candidates, focusing on delivering results for all parties, we are Dedicated to Life Science talent.

Find Us
Website
Telephone
+44 (0)203 865 5705
Location
154-158 Shoreditch High Street
London
England
E1 6HU
GB

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