For our customer located in Basel/Switzerland we are currently looking for a: Regulatory Affairs Manager (m/f/d)
- Location: CH-Basel
- Duration: asap – 31.12.2024
- pay rate: 54.05 chf/h – 60.81 chf/h
Tasks & 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.
BS in life sciences or a relevant discipline with min 5 years of professional work
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.
• Effective interpersonal skills, strong written and oral communication and
• 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
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.