Clinical Dossier Lead Consultant

Location: Basel
Contract: 6-month, with potential for extension 
Start Date: ASAP
Workload: Full-time
Overview:
Our client, a Swiss pharmaceutical company specializing in medicines for rare diseases, is seeking an experienced Clinical Dossier Lead Consultant. This role involves leading the update and submission of major regulatory dossiers.

Key Responsibilities:

• Lead the update of major regulatory dossiers.
• Extract, interpret, and integrate clinical data from several study reports, ensuring consistency and accuracy.
• Collaborate with and provide direction to medical writers for summary of safety, clinical overview, and other key documentation.
• Evaluate long-term safety data for an already submitted dossier and incorporate findings into updated submissions.
• Act as the lead for clinical submissions, ensuring compliance with regulatory standards for NDA and MAA filings.
• Address challenges in the existing dossier structure and improve document quality for clarity and coherence.
• Partner with internal and external teams to align on submission strategies and timelines.

Required Qualifications:

• Advanced degree in life sciences, medicine, or a related field.
• Extensive experience (8+ years) in regulatory affairs, clinical science, or related roles, with a focus on dossier preparation and submissions.
• Proven track record of leading NDA and MAA submissions in the pharmaceutical/biotech industry.
• Ability to navigate and improve poorly structured dossiers with a critical, problem-solving mindset.
• Strong analytical, data interpretation, and regulatory writing skills.
• Excellent communication and leadership skills, with experience guiding cross-functional teams.

**Please apply directly online with your CV and only apply if you are eligible to work in Switzerland and the EU*

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