CMC Dossier Lead for Regulatory Submissions & Strategy

Johnson & Johnson; Beerse; Hybride; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Recognition awards

Service anniversary

Résumé du poste

Johnson & Johnson is seeking a Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development. You will develop technical eCTD sections for regulatory CMC dossiers, coordinate timeline and document generation, and lead dossier authoring with managerial support.

You will interact with Regulatory, project teams and external partners to ensure compliant submissions. The role requires a PhD or equivalent with 3+ years post-doc or a Bachelor's/Master's with 6+ years in pharma,

Qualifications

• Proven experience in dossier authoring for regulatory filings in CMC.
• Familiarity with eCTD format and regulatory guidelines (FDA/EMA).
• Experience leading cross-functional teams and coordinating resources.

Responsabilités

• Develops technical eCTD sections for Regulatory CMC dossiers.
• Coordinates timeline and document generation for regulatory submissions.
• Leads dossier authoring with some managerial guidance.
• Drives process improvements and regulatory strategy.
• Represents department on multi-functional project teams.

Connaissances

Dossier authoring

Regulatory submissions

Leadership

Project management

Regulatory strategy

Strong communication

Cross-functional collaboration

Formation

PhD with 3+ years post-doc

Bachelor/Master 6+ years experience in pharma

Description du poste

Johnson & Johnson is seeking a Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development. You will develop technical eCTD sections for regulatory CMC dossiers, coordinate timeline and document generation, and lead dossier authoring with managerial support.

You will interact with Regulatory, project teams and external partners to ensure compliant submissions. The role requires a PhD or equivalent with 3+ years post-doc or a Bachelor's/Master's with 6+ years in pharma,