Global Regulatory CMC Lead Scientist

Johnson & Johnson; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is seeking a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities in Beerse (Belgium), Warsaw (Poland) or East Coast USA. You will influence global CMC regulatory strategies and drive readiness for regulatory submissions across multiple locations.

You will lead regulatory activities, collaborate with global teams, and ensure compliance with health authority expectations while supporting development and potential marketed products in a dynamic, matrixed environment.

Qualifications

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 6+ years of experience; an MS, Ph.D., or Pharm. D. degree preferred.
• Demonstrated ability to communicate regulatory requirements.
• Strong attention to detail with high-level verbal and written communication skills.
• Experience interacting with Health Authorities under supervision of a senior CMC RA staff.

Responsabilités

• Contributes to the development of global CMC regulatory strategies and dossier plans with Global CMC Regulatory Affairs personnel.
• May participate as the Regulatory CMC Lead on CMC Teams and provide regulatory input to GRT to facilitate global product development.
• Supports global regulatory filings for developmental compounds and possibly marketed products.
• Prepares regulatory dossiers for submission to Health Authorities under supervision.
• Coordinates and manages CMC country-specific documents for global submissions.
• Assists in developing CMC Health Authority responses per strategy.
• Drives continuous improvement to ensure compliance with Johnson & Johnson standards.

Connaissances

Regulatory communication

Cross-functional teamwork

Attention to detail

Verbal and written communication

Formation

BS in life sciences (biological/pharmaceutical/chemical/engineering)

MS/PhD/PharmD preferred

Description du poste

Johnson & Johnson is seeking a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities in Beerse (Belgium), Warsaw (Poland) or East Coast USA. You will influence global CMC regulatory strategies and drive readiness for regulatory submissions across multiple locations.

You will lead regulatory activities, collaborate with global teams, and ensure compliance with health authority expectations while supporting development and potential marketed products in a dynamic, matrixed environment.