Global Regulatory Submission Publisher

Vor 5 Tagen

Basel, Schweiz Warman O'Brien Vollzeit

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 high-quality 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.
- 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.
- EU/EFTA Citizen or valid Swiss work Permit

**Role Details**:

- Long-term contract - 18 months+
- Global Pharma
- Competitive rates of pay
- Hybrid working considered

**Job Types**: Full-time, Freelance

**Salary**: CHF69.00 - CHF71.00 per hour

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Basel, BS: Reliably commute or planning to relocate before starting work (required)

Work Location: One location

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