Director Regulatory CMC

My client is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical needs to help improve the lives of patients with serious eye disorders. With 5- approved products with a growing pipeline and 4-more in the pre-clinical stage, this is the perfect time to join this growing team.

Overview: 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 the 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 the 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 CMC meetings with health authorities.
• Shepherd proactive interactions with regulators; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections.

Qualifications:

• Number of Years of Experience in the Function and in the Industry: Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs.
• Bachelor of Science in a scientific discipline, advanced degree highly preferred.
• Extensive experience in pharmaceutical submissions is required.
• Evidence of successful submissions to FDA and demonstrated evidence of writing regulatory documents.
• At a minimum, 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.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence greater outcomes is a plus.
• Strong knowledge of current Good Manufacturing Practices (GMP), drug development regulations, and guidelines, including ICH, and FDA guidelines.
• Proficient in the use of Electronic Data Management Systems (EDMS) and experience with Veeva Vault is strongly preferred.

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