CMC Dossier Lead for Regulatory Submissions

Johnson & Johnson; Leiden; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson is seeking a Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development to lead regulatory dossiers and provide technical oversight for submissions. You will coordinate timelines, manage cross-functional teams, and ensure compliance with global regulatory requirements.

The role requires strong expertise in CMC, eCTD submissions, and experience guiding both synthetic and biologic products.

Qualifications

• Experience with dossier authoring for synthetic and/or biologic products is required.
• Familiarity with CMC regulatory submissions (eCTD) and guidelines (FDA/EMA) is preferred.
• Ability to lead complex regulatory projects and coordinate cross-functional teams.

Responsibilities

• Lead dossier authoring activities for early and late-phase regulatory filings with some managerial support.
• Coordinate timelines and generate Quality and regulatory modules for submissions.
• Mentor colleagues and supervise consultants when needed.
• Collaborate with internal teams and external partners to enable timely filings.

Skills

Dossier authoring

Regulatory submissions

Leadership

Communication skills

Project management

Strategic planning

Cross-functional collaboration

Regulatory knowledge

Education

PhD + post-doc experience

Bachelor’s or Master’s in chemical/biological/pharmaceutical sciences

Job description

Johnson & Johnson is seeking a Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development to lead regulatory dossiers and provide technical oversight for submissions. You will coordinate timelines, manage cross-functional teams, and ensure compliance with global regulatory requirements.

The role requires strong expertise in CMC, eCTD submissions, and experience guiding both synthetic and biologic products.