Associate Director, Regulatory Affairs – CMC

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🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $222.4k - $240k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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BlueRock Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 $225M Series A - BlueRock Therapeutics on 2016-12

Biotechnology • Healthcare • Pharmaceuticals

BlueRock Therapeutics is a clinical-stage cell therapy company developing next-generation medicines that replace cells damaged or lost to disease. The company focuses on regenerative cell therapies with clinical programs in neurology (notably bemdaneprocel for Parkinson’s disease) and ophthalmology, and lists investigational candidates such as OpCT-001. BlueRock emphasizes transforming treatment of degenerative diseases, progressing programs through clinical trials and receiving regulatory designations (e. g. , Orphan Drug and Pioneering Regenerative Medical Product).

📋 Description

• Provide regulatory leadership and guidance to CMC teams developing cell and gene therapy products • Oversee and generate quality dossiers for Health Authority meetings, clinical trial applications, and market applications in the U.S. and international territories • Represent Regulatory CMC on and/or lead matrix teams for cell and gene therapy pipeline products • Provide strategic guidance related to regulatory requirements and expectations for clinical trial and marketing applications • Manage and prioritize multiple complex projects • Drive Health Agency interaction workflows, including briefing documents and responses to questions • Interface with Health Authorities on CMC submissions and CMC-related issues • Identify, communicate, and propose resolutions to routine and complex strategic issues • Interpret global regulations and guidance and identify regulatory opportunities and risks • Review and provide regulatory assessments on change controls • Prepare and manage CMC submissions for global markets, including creation and maintenance of strategy documents • Manage relationships with diverse technical and project teams • Utilize electronic systems for dossier creation and tracking • Support departmental initiatives, special projects, budgeting, and authoring departmental documents

🎯 Requirements

• Bachelor’s degree or equivalent in Regulatory Science or related field • 6 years of experience in Regulatory Affairs, CMC • Experience in a global pharmaceutical and/or biotechnology company • Expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products • Direct experience interfacing with regulatory authorities • Extensive experience preparing quality sections of regulatory filings, including Health Authority briefing documents, IND/CTA, and NDA/BLA/MAA • Ability to lead regulatory CMC discussions with global regulatory authorities • Experience preparing electronic submissions following eCTD format • Knowledge and understanding of U.S., international regulations, and ICH guidelines related to biologics and cell therapy development • Experience leading the development and implementation of complex regulatory strategies, with significant regulatory accomplishments • Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions • Ability to understand regulatory impacts of manufacturing and quality control changes • Ability to collaborate effectively with process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations experts • Excellent written and communication skills with attention to detail • Highly computer literate, including Word, Excel, and PowerPoint, and formatting documents for regulatory submission

🏖️ Benefits

• Fully remote work / telecommuting permitted • 25% travel within US/Canada, with some additional limited EU travel possible • Equal opportunity workplace • Disability-related and other legally protected-ground accommodation during recruitment