Global Regulatory Submission Publisher

Employer
CTC Resourcing Solutions
Location
Basel
Salary
None
Start date
22 Nov 2022
Closing date
22 Dec 2022

View more

You need to sign in or create an account to save a job.

Job Details

The Life Science Career Network


CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.


Global Regulatory Submission Publisher – (5088-LBD)


Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an Global Regulatory Submission Publisher for 24 month contract role based in Basel, Switzerland. The stat date is: 05.12.2022 until 31.12.2024.


This role is an individual contributor position in GDD Regulatory Affairs Operations accountable for all publishing, verification, dispatch and coordination of HA compliant, worldwide regulatory submissions in support of NVS global product portfolios.


Main Responsibilities:


  • Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool) and dispatch activities related to regulatory submissions (i.e., INDs, BLAs/NDAs, MAAs, HA A to Qs, Global Labeling, Annual Reports, etc.).
  • Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements US, EU, LACan, MOW).
  • Partners with Operations Submission Managers and a publishing team located in 3 regions (US, EU and India) and actively functions in a global capacity.
  • Liaises /collaborates with cross functional team members and document authors (Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high-quality submissions.
  • Comply with and actively apply internal work practices and guidelines.
  • Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
  • Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
  • Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.


Qualifications and Experience:


  • Swiss working/residency permit and/or Swiss/EU-Citizenship required
  • BS in life sciences or a relevant discipline with min 5 years of professional work
  • experience.
  • Fluent in English (Strong oral and written skills required). Additional language is an
  • asset.
  • 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.
  • Strong skills and Publishing and Validation�
  • 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.

Would you like to learn more about CTC and the opportunity outlined?� Please, get in contact with us:� you may either use the 'apply now' button, or write an email to us.

Company

Due to our reputation for excellence and our proactive approach to networking and promoting CTC, we are able to engage the very best talent, and consequently work with the very best employers in the market who are serious about bringing talent to their organisation. If you are looking for a reliable partner with:

  • Established client and candidate network
  • Excellent and detailed knowledge of local requirements
  • Solid reputation
  • Quick and flexible approach to recruitment
  • High quality of service
  • People focused

Depending on your needs and situation, we offer business partnerships with flexible solutions that can be tailored to your specific resourcing needs - all with a collaborative, open, and friendly approach.

We recruit in the following areas:

  • Pharma/Biotech:
    • Clinical Development
    • Pre-Clinical Development
    • Regulatory affairs
    • Pharmacovigilance
    • Sales & Marketing
    • Supply Chain
    • Communications
    • Medical Affairs
    • General Management
  • Medical Devices / MedTech:
    • Engineering & Product Development
    • Quality & Manufacturing
    • Technical Writing
    • Regulatory Affairs
    • Sales & Marketing
Find Us
Website
Telephone
+41 61 695 88 66
Location
Münchensteinerstrasse 41
Münchensteinerstrasse 41
4052
Basel
CH
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert