CMC Dossier Lead - Regulatory Submissions & Strategy

Johnson & Johnson; Beerse; Sur place; EUR 83 000 - 165 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Health & well-being programs

Résumé du poste

Johnson & Johnson Beerse, Belgium, is seeking a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development. The role develops the technical eCTD sections for regulatory CMC submissions and coordinates the generation of the CMC dossier for marketing and clinical trials, ensuring compliance and timely delivery.

You will lead dossier authoring with limited managerial guidance, supervise up to 15 team members, collaborate across functions, and drive process

Qualifications

• PhD with 6+ years post-doc (or BSc/MSc with 8+ years in relevant fields).
• Experience leading dossier authoring for synthetic and/or biologic products.
• Familiarity with regulatory submissions (FDA/EMA) and eCTD guidelines.

Responsabilités

• Develops technical eCTD sections for CMC dossiers and coordinates document generation.
• Leads dossier authoring activities for regulatory filings with limited supervision.
• Drives process improvements and ensures regulatory compliance across submissions.
• Collaborates with internal/external partners and supervising teams up to 15 members.

Connaissances

Dossier leadership

CMC submissions

Regulatory strategy

Cross-functional collaboration

Project management

Communication

Mentoring

Formation

PhD in chemical/biological/pharma sciences

Outils

eCTD expertise

Description du poste

Johnson & Johnson Beerse, Belgium, is seeking a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development. The role develops the technical eCTD sections for regulatory CMC submissions and coordinates the generation of the CMC dossier for marketing and clinical trials, ensuring compliance and timely delivery.

You will lead dossier authoring with limited managerial guidance, supervise up to 15 team members, collaborate across functions, and drive process