Senior Scientist, Product Lead CMC Regulatory Affairs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-100114
• Belgium, Poland - Requisition Number: R-101274

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities.  This position is a hybrid role and can be located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA.

The Senior Scientist Product Lead CMC Regulatory Affairs - Synthetics, New Modalities will be responsible for the following:

• 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.

Additional Description for Pay Transparency: