CMC Regulatory Lead Scientist – Product Strategy

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

Benefits offered by this job

Vacation time – generous PTO

Sick time – per policy

Medical & dental benefits

Job summary

Johnson & Johnson Innovative Medicine R&D is recruiting for 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 across biology, pharmacology, and clinical data and contribute to global CMC regulatory plans. You will support regulatory filings, prepare dossiers, and coordinate country-specific documents while ensuring compliance

Qualifications

• A minimum of a Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline is required. Advanced degree (Master’s, PharmD, Ph.D.) preferred.
• A minimum of 4 years of related pharmaceutical or health care industry experience, inclusive of post graduate education.
• Solid understanding of biology, chemistry and/or engineering, relevant to the pharmaceutical industry.
• Prior drug development, analytical development, or manufacturing experience.
• Experience interacting with Health Authorities independently or under the supervision of CMC Regulatory Affairs staff.
• Working knowledge of global Health Authority laws, regulations and guidances.
• The ability to present and defend CMC management-approved regulatory strategy and opinion to project teams.
• The ability to communicate regulatory requirements to stakeholders cross-functionally and cross-company.
• Excellent verbal and written communication skills.
• Strong attention to detail.

Responsibilities

• Drive scientific strategy and critical decision-making through integration of disease biology, pharmacology, biomarkers, human genetics, and clinical data.
• Contribute to the development of global CMC (Chemistry, Manufacturing, and Controls) regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other Global CMC Regulatory Affairs (CMC RA) personnel.
• May participate as the Regulatory CMC Lead on CMC Teams and represent CMC RA by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations.
• Support global regulatory filings for mainly development compounds, and potentially also marketed products, in collaboration with other CMC RA senior personnel.
• Prepare regulatory dossiers for submission to Health Authorities under supervision.
• Coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions.
• Assist in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
• May participate in selected initiatives within CMC RA/GRA.
• Drive a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicate critical issues to Management.
• May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds (and marketed products).
• Ensure the CMC regulatory strategy is in alignment with the strategies of global Regulatory Affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP).
• Assure connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader) or other senior level CMC RA personnel.
• Provide input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
• Assist in providing accurate regulatory assessments of CMC changes to teams for execution of regulatory planning and implementation.
• Escalate issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product.
• Assist in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Provide CMC Regulatory support to health authority inspections.

Education

Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline

Job description

Johnson & Johnson Innovative Medicine R&D is recruiting for 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 across biology, pharmacology, and clinical data and contribute to global CMC regulatory plans. You will support regulatory filings, prepare dossiers, and coordinate country-specific documents while ensuring compliance