Senior Principal Scientist, CMC Dossier Development
Johnson & Johnson
Senior Principal Scientist, CMC Dossier Development
Johnson & Johnson is seeking a Senior Principal Scientist for CMC Dossier Development to lead the technical eCTD sections for regulatory CMC dossier applications, coordinating and providing technical oversight for marketing and clinical trial submissions. The role requires a PhD with 6+ years of experience or a Bachelor's/Master's with 8+ years, expertise in dossier authoring for synthetic and/or biologic products, and familiarity with CMC regulatory submissions and eCTD format. This is a full-time, remote position based in Leiden, Netherlands.
Senior Principal Scientist, CMC Dossier Development
Johnson & Johnson is seeking a Senior Principal Scientist for CMC Dossier Development to lead the technical eCTD sections for regulatory CMC dossier applications, coordinating and providing technical oversight for marketing and clinical trial submissions. The role requires a PhD with 6+ years of experience or a Bachelor's/Master's with 8+ years, expertise in dossier authoring for synthetic and/or biologic products, and familiarity with CMC regulatory submissions and eCTD format. This is a full-time, remote position based in Leiden, Netherlands.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- Supports and implements dossier strategy/product development plans with autonomy.
- Leads and supervises dossier authoring activities for early and late-stage regulatory filings.
- Identifies and drives business improvements within the functional organization.
- Collaborates with CMC/Tech team members, Regulatory, J&J Innovative Medicine Supply Chain, external service providers, and internal customers.
- Influences alignment on new ideas and approaches with internal and external partners.
- Handles complex projects with potentially accelerated priority or programs in NDA/BLA phase.
- Challenges the status quo and identifies innovative process improvements.
- Makes day-to-day operational decisions and allocates resources.
- Leads functional or cross-functional teams of up to 15 members.