(Sr) Director, Regulatory CMC

Overview

EyePoint Pharmaceuticals, Inc. is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders.

Reporting directly to the Head of Regulatory Affairs and Quality Assurance, the Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions. In this position, you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with our in-house CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, strategic partners, and health authorities.

Responsibilities

• Provide regulatory CMC strategic leadership to support development of multiple innovative products
• Write CMC technical reports as source documents and eCTD sections for INDs, and NDAs.
• Develop CMC response strategies and submissions to regulators
• Manage completion of CMC submission documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
• Develop CMC briefing packages for meetings with health authorities
• Lead the preparation for and conduct of CMC meetings with health authorities
• Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
• Provide critical review of all CMC documentation supporting regulatory applications
• Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable regulatory and filing implementation
• Identify and assess CMC regulatory risks
• Prepare and deliver effective presentations for internal and external audiences

Qualifications

• Bachelor of Science in a scientific discipline, advanced degree highly preferred.
• Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs.
• Extensive experience in pharmaceuticals submissions required.
• Evidence of successful submissions to FDA and demonstrated evidence of writing of regulatory documents.
• At a minimum, established working knowledge of US guidelines and regulations.
• Established working knowledge of US guidelines and regulations.
• Strong knowledge of eCTD elements and structure and regulatory technical writing skills.
• Regulatory experience supporting both development projects and commercial products.