Regulatory CMC Contractor/Consultant

Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Consultant/Contractor to prepare and review CMC sections of INDs, IMPDs, CTAs, and also post-approval changes.  Reporting to the Head of Regulatory Affairs, you will work in close collaboration with Regulatory Operations, Quality, and Technical Operations. This engagement will be  30-40 hours per week for approximately 3-6 months.  This client would prefer contractors/consultants in the Northeast who can travel to the Boston-area office as needed.


  • Manage completion of high quality CMC submission documents and other assigned tasks within established timelines, in coordination with Regulatory Operations.
  • Ensure that CMC documents are high quality in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
  • Prepare and finalize CMC supplements for two approved NDAs and CMC amendments for three active INDs.
  • Prepare and finalize Annual Report CMC sections for NDA Annual Report, IND Annual Report and/or DSUR- Regional Information.
  • Review and approve CMC technical reports as source documents, as per procedures, in coordination with Quality.
  • Provide critical review of all CMC information supporting regulatory applications, including CMC sections of Investigators’ Brochure, labeling, etc.
  • Identify and assess CMC regulatory risks.



  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
  • Five or more years of experience in Regulatory CMC for pharmaceutical drugs.
  • Experience authoring CMC modules for sterile injectables and drug-device combination products.
  • Track record of successful CMC submissions to FDA and demonstrated evidence of writing of regulatory documents.
  • Strong working knowledge of US guidelines and regulations. Specifically, regulatory requirements of drug-led-device combination (e.g., pre-filled syringes, injectables and ophthalmic products.
  • Experience with ophthalmic products desired.
  • Strong knowledge of eCTD elements and structure and regulatory technical writing skills.
  • Experience in reviewing Post-approval change controls, assess regulatory impact and purpose regulatory CMC supplement strategy.
  • Excellent writing skills for communicating technical and scientific information to US FDA.
  • Working knowledge of CMC Word templates and eCTD requirements for US FDA and use of Adobe Acrobat Pro DC Experience in ophthalmic products is preferred.
  • Strong knowledge of current Good Manufacturing Practices (GMP), drug development regulations and guidelines including ICH, and FDA guidelines
  • Proficient in Microsoft Office suite and applications.

*Note:  All candidates must be authorized to work in the United States.  Client cannot support visa or visa transfer

Apply for this Position

    Your Name*

    Your Email*


    Your Message

    This entry was posted in . Bookmark the permalink.