Lead CMC Dossier Scientist for Regulatory Submissions

Johnson & Johnson; Leiden; On-site; EUR 96,000 - 165,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Leiden, Netherlands, invites a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development, to lead regulatory CMC dossiers for marketing and clinical submissions. You will coordinate timelines, author sections, and ensure regulatory compliance across FDA/EMA guidelines.

You will supervise dossier authoring activities, work with multi-disciplinary teams, and drive strategic plans for product timelines while mentoring colleagues and delivering

Qualifications

• PhD with 6+ years post-doc or equivalent in chemical/biological/pharmaceutical sciences.
• Experience leading CMC dossier authoring for synthetic or biologic products.
• Familiarity with FDA/EMA regulatory guidelines and eCTD.
• Experience coordinating regulatory submissions and cross-functional teams.

Responsibilities

• Supports dossier strategy and development plans with autonomy.
• Leads dossier authoring for early and late-stage regulatory filings with limited supervision.
• Drives business improvements within the function and with other departments.
• Collaborates with CMC, Regulatory, Supply Chain, and external partners.
• Influences alignment on new ideas and approaches with partners.
• Combines technical expertise with managerial skills; may supervise consultants.
• Handles complex projects or NDA/BLA programs with accelerated priority.
• Identifies innovative process improvements and challenges status quo.
• Makes day-to-day decisions and allocates resources; reports to supervisor.
• Leads functional or cross-functional teams of up to 15 members.

Skills

Dossier leadership

CMC regulatory submissions

eCTD knowledge

Project leadership

Cross-functional collaboration

Regulatory writing

Strategic planning

Team mentoring

Communication skills

Analytical thinking

Independent work

Education

PhD with 6+ years post-doc

Bachelor's/Master's in chemical/biological/pharma with 8+ years

Job description

Johnson & Johnson in Leiden, Netherlands, invites a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development, to lead regulatory CMC dossiers for marketing and clinical submissions. You will coordinate timelines, author sections, and ensure regulatory compliance across FDA/EMA guidelines.

You will supervise dossier authoring activities, work with multi-disciplinary teams, and drive strategic plans for product timelines while mentoring colleagues and delivering