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