Senior Scientist, CMC Regulatory Lead (Hybrid)

Johnson & Johnson Innovative Medicine; Titusville (NJ); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental leave

Volunteer leave

Long-term incentive program

Job summary

Johnson & Johnson Innovative Medicine in the U.S. is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities.

This hybrid role can be located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA, and offers an opportunity to drive regulatory strategy across global programs. You will lead regulatory strategy for CMC, coordinate dossiers, support filings, and partner with teams to ensure compliance with Health Authority expectations, while shaping

Qualifications

• Bachelor's degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or related field.
• 4+ years in pharmaceutical or healthcare industry with drug development or manufacturing experience.
• Experience interacting with Health Authorities independently or under supervision.
• Knowledge of global Health Authority laws, regulations and guidances.
• Ability to present regulatory strategy to project teams.

Responsibilities

• Drive scientific strategy integrating biology, pharmacology, biomarkers and clinical data.
• Contribute to global CMC regulatory strategy and dossier plans.
• Lead or participate in CMC teams and regulatory leadership activities.
• Support global regulatory filings for development compounds.
• Prepare regulatory dossiers for Health Authority submissions.
• Coordinate CMC documents for global submissions.
• Develop and respond to Health Authority queries as needed.

Skills

CMC Regulatory Affairs

Regulatory Strategy

Global Health Authority

Regulatory Documentation

Education

Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences

Job description

Johnson & Johnson Innovative Medicine in the U.S. is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities.

This hybrid role can be located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA, and offers an opportunity to drive regulatory strategy across global programs. You will lead regulatory strategy for CMC, coordinate dossiers, support filings, and partner with teams to ensure compliance with Health Authority expectations, while shaping