CMC Dossier Lead for Regulatory Submissions

Leiden Bio Science Park; Leiden; On-site; EUR 120,000 - 180,000; Full time

Job summary

Leiden Bio Science Park is seeking a Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development to lead the technical eCTD sections for regulatory filings, coordinating the creation of CMC dossiers for marketing and clinical trial submissions.

With managerial guidance, you will own dossier timelines, oversee cross-functional teams, and drive strategic improvements while ensuring compliance with FDA/EMA guidelines.

Qualifications

• PhD or higher with 3+ years post-doc experience OR Bachelor's/Master's with 6+ years in related field
• Experience drafting/regulatory CMC documents for marketing and clinical trial submissions
• Familiarity with CMC regulatory submissions, eCTD format, and guidelines (FDA/EMA)
• Experience leading complex regulatory projects in pharma/biotech
• Proven ability to lead cross-functional teams and manage timelines
• Strong written and oral communication skills
• Ability to work independently and mentor colleagues

Responsibilities

• Lead dossier authoring activities for regulatory filings
• Coordinate and oversee generation of CMC dossiers
• Represent department on multi-functional project teams
• Drive process improvements within the functional organization
• Mentor colleagues and supervise consultants when needed
• Ensure compliance with regulatory requirements across submissions

Skills

Dossier leadership

Regulatory strategy

Project management

Cross-functional collaboration

Communication (written & oral)

Education

PhD in chemical/biological/pharmaceutical sciences

Bachelor's/Master's in related field

Job description

Leiden Bio Science Park is seeking a Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development to lead the technical eCTD sections for regulatory filings, coordinating the creation of CMC dossiers for marketing and clinical trial submissions.

With managerial guidance, you will own dossier timelines, oversee cross-functional teams, and drive strategic improvements while ensuring compliance with FDA/EMA guidelines.