Senior Scientist, CMC Regulatory Lead

Johnson & Johnson Innovation; Horsham (PA); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

401(k)

Paid time off

Healthcare benefits

Job summary

Johnson & Johnson Innovative Medicine is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. The role supports global regulatory strategies across development compounds and may involve marketed products.

The position is hybrid and can be located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA. Strong regulatory communication and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or related field.
• Advanced degree (Master’s, PharmD, Ph.D.) preferred.

Responsibilities

• Drive scientific strategy and decision-making by integrating biology, pharmacology, biomarkers, genetics and clinical data.
• Contribute to global CMC regulatory strategies and dossier plans with CMC RA colleagues.
• May serve as Regulatory CMC Lead on teams and provide regulatory expertise to global teams.
• Support global regulatory filings for development compounds and possibly marketed products.
• Prepare regulatory dossiers for Health Authorities under supervision.
• Coordinate and manage CMC country-specific documents for global submissions.
• Assist in developing responses to Health Authority inquiries as needed.
• Ensure compliance with Johnson & Johnson standards and regulatory expectations.

Skills

Communication skills

Attention to detail

Analytical thinking

Regulatory knowledge

Education

Bachelor’s degree in Biological/Pharmaceutical/Chemical/Engineering

Advanced degree preferred (Master’s/Ph.D.)

Job description

Johnson & Johnson Innovative Medicine is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. The role supports global regulatory strategies across development compounds and may involve marketed products.

The position is hybrid and can be located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA. Strong regulatory communication and cross-functional collaboration are essential.