Global Regulatory Submission Publishing Associate (897287-MST)
- Experience Level
- Entry level
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Global Regulatory Submission Publishing Associate to be based in Basel for a 18-month contract position.
As a Global Regulatory Submission Publishing Associate you are accountable for all publishing, verification, coordination and dispatch of HA compliant, worldwide regulatory submissions in support of our clients global product portfolio.
- Create, assemble and publish electronic submissions per regulatory requirements with a focus on maintenance submissions worldwide (variations, Response to List of Questions etc);
- Coordinates internal publishing activities and liaises with cross functional teams and document authors to assist with timelines and deliverables related to submission document;
- Conducts quality control review tasks,
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- Bachelor’s Degree in life sciences or a relevant discipline with 3-5 years of professional work experience in Pharma or related industry;
- Familiar with regulatory requirements and good knowledge on regulatory submission format, particularly CTD/eCTD;
- Strong interpersonal communication skills and ability to work effectively in cross-functional teams;
- Proficiency with MS office and publishing software (e.g. eCTDXpress, DocuBridge, etc.);
- Fluent in English (strong oral and written skills).