Senior Scientist, Product Lead - CMC Regulatory

Johnson & Johnson Innovative Medicine

Horsham (PA)

Hybrid

USD 109,000 - 175,000

Full time

27 hours ago

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Benefits offered by this job

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Job summary

Johnson & Johnson Innovative Medicine R&D seeks 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.

You will drive scientific strategy, contribute to global CMC regulatory plans, and participate as a regulatory lead on cross-functional teams to enable development from laboratory concepts to validated medicines.

Qualifications

Bachelor’s degree is required; advanced degree preferred.
4+ years in pharmaceutical or health care industry.
Experience with Health Authorities independently or under supervision.
Knowledge of global health authority laws, regulations and guidances.

Responsibilities

Drive scientific strategy integrating biology, pharmacology, biomarkers and clinical data.
Contribute to global CMC regulatory strategies and dossier plans.
May lead as Regulatory CMC Lead on CMC Teams and represent CMC RA on teams.
Support global regulatory filings for development compounds and possibly marketed products.
Prepare regulatory dossiers for submission to Health Authorities.
Coordinate and manage CMC country-specific documents for global submissions.
Assist in developing CMC Health Authority responses as needed.
Drive continuous improvement to ensure compliance with Johnson & Johnson standards.
Provide input to global regulatory strategy alignment with therapeutic area and QA.