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Sanofi Group Technical Writer CMC Module 3 in Bridgewater, New Jersey

Position Overview:

The Regulatory CMC Template/Content Editor will be part of the Regulatory Affairs CMC department and will be responsible for ensuring the creation, standardization, editing and management of content within Chemistry, Manufacturing, and Controls (CMC) regulatory documents for Sanofi portfolio related to all pre marketing activities (initial submissions) in all regulatory jurisdictions with a primary focus on the United States and Europe.

Responsibilities include, but are not limited to the following:

  • Work closely with internal RACMC, IA and Quality functions as needed to establish high quality Module 2 and 3 CMC regulatory templates across Sanofi Portfolio for health authority submissions , e.g. Investigational New Drug applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), Drug Master Files (DMFs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs);

  • Work closely with internal RACMC, IA and Quality functions as well as Contract Manufacturing Organizations (CMOs) as needed to edit high quality Module 2 and 3 CMC regulatory documents for health authority submissions, e.g. Investigational New Drug applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), Drug Master Files (DMFs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs);

  • For RACMC, Lead the development, writing, and editing of CMC related technical data for inclusion in Module 3 of the electronic Common Technical Document (eCTD). This will include information from Standard Operating Procedures (SOPs), Batch Records, stability protocols, process validation reports, etc. as part of preparing INDs, IMPDs, NDAs and MAAs Module 3 sections, related Module 2 Quality Overall Summary (QOS) documents, briefing documents, and other documents needed to support regulatory meetings, marketing applications, and life cycle management documents;

  • Review, prepare, manage, and lead responses to CMC related questions from Regulatory Authorities (such as US FDA, EMA, MHRA, Health Canada, others) as required to ensure that key messages are clear and consistent across documents and participate in CMC related meetings with Regulatory Authorities as needed;

  • Perform reviews of documents prepared by other team members for completeness, accuracy, structure, and grammar;

  • Consolidate RACMC information related to Active Pharmaceutical Ingredient (API) and finished drug product Module 3 sections in compliance with The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), US Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization (WHO), and other Regulatory Authorities CMC related regulations and guidelines;

  • Work closely with Regulatory Affairs, Analytical Development, Quality Control, Quality Assurance, Process Development and Manufacturing to communicate document-specific timelines to team members to ensure on-time deliverables are completed;

  • Establishing strategies for document authoring, contributing strategically and scientifically at the project level, directing external partners with regard to document quality.

  • Provided guidance and leadership for document development for regulatory filings.

  • Understand and implement current industry standards and techniques for quality regulatory submissions.

Competencies include, but are not limited to the following:

  • Demonstrated experience in template creation and M3 content requirements

  • Strong Project Management, Leadership and Documentation Management skills

  • Detailed knowledge and experience of current M2/M3 expectations globally

  • Working knowledge of Digital/AI considerations for submission content

Qualifications include, but are not limited to the following:

  • 8-10 years’ experience in Regulatory Field preparing Chemistry Manufacturing Control (CMC) submissions / dossiers (Product Support, Regulatory Operations).

  • Minimum BA/BS Degree

  • Extensive knowledge and experience in the creation and management of Templates, formatting and formatting toolbars

  • Proficiency of most up-to-date regulatory standards (FDA, EMA, PFDA, and ICH) based on the internationally accepted Common Technical Document (CTD) Format

  • Expertise in the required content and Agency-preferred presentation of CTD Module 2.3 and Module 3

  • Proficiency with relevant regulatory guidances (US FDA, EMA, MHRA, Health Canada, etc.)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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