Associate Director, Regulatory Affairs – CMC

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Offer regulatory leadership and expertise to CMC teams focused on developing cell and gene therapy products

• Oversee the creation and management of quality dossiers for Health Authority meetings, clinical trial applications, and market applications in both the U.S. and international regions

• Represent Regulatory CMC on and/or lead cross-functional teams for cell and gene therapy pipeline products

• Provide strategic direction regarding regulatory requirements and expectations for clinical trial and marketing applications

• Manage and prioritize a variety of complex projects

• Facilitate Health Agency interaction workflows, including the preparation of briefing documents and responses to inquiries

• Liaise with Health Authorities on CMC submissions and related issues

• Identify, communicate, and propose solutions to both routine and complex strategic challenges

• Interpret global regulations and guidance, pinpointing regulatory opportunities and risks

• Review and provide regulatory evaluations on change controls

• Prepare and manage CMC submissions for worldwide markets, including the development and maintenance of strategic documents

• Foster relationships with diverse technical and project teams

• Utilize electronic systems for dossier creation and monitoring

• Support departmental initiatives, special projects, budgeting, and the drafting of departmental documents

⛳️ Requirements

• Bachelor’s degree or equivalent in Regulatory Science or a related field

• 6 years of experience in Regulatory Affairs, CMC

• Experience in a global pharmaceutical and/or biotechnology organization

• Expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products

• Direct experience interacting with regulatory authorities

• Extensive experience preparing high-quality sections of regulatory submissions, including Health Authority briefing documents, IND/CTA, and NDA/BLA/MAA

• Ability to lead regulatory CMC discussions with global regulatory bodies

• Experience preparing electronic submissions in compliance with eCTD format

• Knowledge of U.S. and international regulations, along with ICH guidelines pertaining to biologics and cell therapy development

• Experience in leading the formulation and execution of complex regulatory strategies, demonstrating significant regulatory achievements

• Capability to comprehend technical aspects of manufacturing and quality control assays and articulate them in regulatory submissions

• Understanding of regulatory implications of manufacturing and quality control changes

• Ability to collaborate effectively with experts in process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations

• Exceptional written and verbal communication skills with a strong attention to detail

• Highly proficient in computer applications, including Word, Excel, and PowerPoint, with experience in formatting documents for regulatory submissions

🏝️ Benefits

• Fully remote work / telecommuting allowed

• 25% travel within the US/Canada, with some potential limited travel to the EU

• Equal opportunity employer

• Accommodations related to disability and other legally protected grounds during recruitment