Senior CMC Dossier Lead – Regulatory Science

Johnson & Johnson Innovative Medicine; Beerse; Hybride; EUR 83 000 - 144 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being programs

Insurance plans

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a Senior Principal Scientist, CMC Dossier Development, to lead technical eCTD sections and regulatory submissions for marketing and clinical trial filings. You will coordinate document generation, oversee timelines, and ensure regulatory compliance.

The role requires strong leadership, communication, and collaboration across Regulatory, Tech, Supply Chain, and external partners to drive innovative solutions in a complex regulatory landscape.

Qualifications

• PhD with 6+ years post-doc experience OR Bachelor/Master with 8+ years in chemical, biological or pharmaceutical sciences.
• Proven ability to lead dossier authoring for synthetic and/or biologic products, with cross-modality leadership potential.

Responsabilités

• Supports and implements dossier strategy/product development plans with autonomy.
• Leads dossier authoring activities for early and late-stage regulatory filings with limited or no managerial support.
• Identifies and drives business improvements within the functional organization and collaborates with other departments as needed.
• Collaborates with Regulatory, CMC/Tech, Supply Chain and external providers on multi-functional project teams.
• Mentors colleagues, coordinates resources and leads cross-functional teams up to 15 members.

Connaissances

Dossier authoring leadership

Regulatory submissions

Regulatory strategy

Project leadership

Communication skills

Problem solving

Independent work

Formation

PhD with 6+ years post-doc

Bachelor/Master in chemical, biological or pharmaceutical sciences with 8+ years

Outils

eCTD format

Description du poste

Johnson & Johnson Innovative Medicine seeks a Senior Principal Scientist, CMC Dossier Development, to lead technical eCTD sections and regulatory submissions for marketing and clinical trial filings. You will coordinate document generation, oversee timelines, and ensure regulatory compliance.

The role requires strong leadership, communication, and collaboration across Regulatory, Tech, Supply Chain, and external partners to drive innovative solutions in a complex regulatory landscape.