Global Regulatory Submission Publisher - Basel, Schweiz - Warman O'Brien

Warman O'Brien

Geprüftes Unternehmen

Basel, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

A Global Regulatory Submissions Publisher is required for a long-term contract with a global pharma based in Basel.

Major Accountabilities:

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 highquality submissions.
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.
58 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.
EU/EFTA Citizen or valid Swiss work Permit

Role Details: