QLS are recruiting for a Global Regulatory Submission Publisher to join a project with a Global Pharmaceutical Company based in Basel on a contract basis for 12 months.
Hybrid or fully remote (needs to be based in Switzerland)
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.
- Ensuring a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
- Ensuring compliance to the requirements from regulatory agencies.
- Maintaining the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
- BS in life sciences or a relevant discipline with min 5 years of professional work experience.
- 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.
- Works independently and with minimal supervision.
- Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly. Analytical skills and problem solving skills.
- Ability to coordinate and work effectively with cross-functional teams
- Languages: Fluent in English (Strong oral and written skills required). Additional language is an asset.
Please could you send any correspondence in English. Please quote job reference 54775 in all correspondence.
You must have the right to work in Switzerland.
- Agency: CK Group
- Reference: 54775
Website: CK Group
- Posted: 23rd November 2022
- Expires: 21st December 2022