Senior CMC Dossier Lead, Regulatory Submissions

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

Job summary

Leiden Bio Science Park is seeking a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development. You will develop technical eCTD sections for regulatory dossiers and oversee cross-functional teams to ensure compliant submissions.

The role requires leading dossier authoring for synthetic or biologic products, with strong CMC regulatory knowledge and excellent communication skills.

Qualifications

• Proven ability to lead dossier authoring for synthetic and/or biologic products.
• Familiar with CMC regulatory submissions, eCTD format and relevant guidelines.
• Experience managing complex regulatory submissions in pharma/biotech.
• Experience collaborating across departments and external partners.
• Strong written and verbal communication with leadership potential.

Responsibilities

• Supports dossier strategy and product development plans with autonomy.
• Leads dossier authoring activities for regulatory filings with limited supervision.
• Identifies and drives business improvements within the function.
• Collaborates with Regulatory, Supply Chain, and cross-functional teams.
• Influences alignment with internal and external partners.
• Mentalities combine technical and managerial skills, may supervise consultants.
• Manages complex projects with potentially accelerated priority.
• Challenges the status quo and identifies process improvements.
• Makes day-to-day decisions and allocates resources independently.

Skills

Dossier authoring

Regulatory submissions

eCTD

CMC

Leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Technical writing

Quality awareness

Education

PhD (6+ yrs post-doc)

Bachelor's degree

Master's degree

Job description

Leiden Bio Science Park is seeking a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development. You will develop technical eCTD sections for regulatory dossiers and oversee cross-functional teams to ensure compliant submissions.

The role requires leading dossier authoring for synthetic or biologic products, with strong CMC regulatory knowledge and excellent communication skills.