CK QLS

Regulatory Writer

Senior Regulatory Writer – 24-Month Contract

Location: Allschwil, Switzerland

Rate: CHF 110–150/hour (depending on experience)

CK QLS is currently recruiting for a Senior Regulatory Writer to join a leading global pharmaceutical company, on a 24-month contract basis. This role offers the opportunity to contribute to high-impact global submissions within a collaborative and fast-paced environment.

Role Overview

The Senior Regulatory Writer will be responsible for independently authoring and reviewing high-quality clinical and regulatory documents to support submissions to global health authorities. The role involves providing scientific and strategic input to project teams, ensuring the effective communication and positioning of clinical data.

Key Responsibilities

• Author and review clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, and Clinical Study Reports (CSRs).
• Prepare responses to health authority questions, briefing documents, safety updates, and investigator brochures.
• Provide scientific and strategic input to submission and study teams.
• Contribute to the planning and presentation of data analyses and review statistical documentation.
• Collaborate with cross-functional stakeholders, including Clinical Sciences, Biometry, Drug Safety, and Regulatory Affairs.
• Work with documentation specialists to ensure timely and high-quality deliverables.
• Support the selection and management of external regulatory writing vendors.
• Mentor and support junior writers.

Candidate Requirements

• Bachelor’s degree in Life Sciences (Master’s degree preferred).
• Minimum of 5 years’ experience in regulatory or medical writing within the pharmaceutical industry.
• Strong knowledge of regulatory guidelines and document requirements.
• Demonstrated ability to produce high-quality clinical and regulatory documentation.
• Experience across multiple therapeutic areas is advantageous.
• Excellent written and verbal communication skills in English.
• Ability to work independently, manage competing priorities, and meet deadlines.

This is an excellent opportunity for an experienced regulatory writer to work on complex global submissions and contribute to the delivery of high-quality regulatory documentation within a leading pharmaceutical environment.

All applications must have the right to work in Switzerland. Please quote 184892 in all communication.