Overview

Be Seen and Heard at EyePoint Pharmaceuticals

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• developing therapeutics to improve the lives of patients with serious retinal disease
• advancing best-in-class proprietary drug delivery technologies
• innovative pipeline of sustained delivery products

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) 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 optimal CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (NDAs/BLAs/MAAs), in close collaboration with our in-house CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, strategic partners, and health authorities.

This position is in Watertown, MA. We offer a hybrid work schedule.

Responsibilities

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

• Provide regulatory CMC strategic leadership to support development of multiple innovative products including life-cycle management and post-marketing changes.
• Review and approve CMC technical reports as source documents, as per procedures, in coordination with Quality.
• 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 EyePoint regulatory guidelines, styles and processes, in coordination with Regulatory Operations.
• Develop CMC section of briefing packages for meetings with health authorities
• Lead the preparation for CMC meetings with health authorities
• For Director-Lead negotiations with regulatory agencies to resolve CMC issues and accountable to lead CMC-specific meetings.
• Shepherd proactive interactions with regulators; prepare and submit responses to CMC questions; support R&D interactions and the Quality Group with regulatory agencies during cGMP and pre-approval inspections.
• Provide critical review of all CMC information supporting regulatory applications, including CMC sections of Investigators’ Brochure, SmPC, and labeling.
• Assess proposed change controls (e.g., manufacturing process changes) and provide strategic regulatory guidance to enable regulatory and filing implementation.
• Identify and assess CMC regulatory risks on key program strategies.
• Prepare and deliver effective presentations for internal and external audiences, as requested
• Must ensure productive interactions between Regulatory CMC, R&D, Quality and Technical Operations and business partners of registration outside USA.
• May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs.

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

Primary skills and knowledge required include, but are not limited to the following:

• Extensive experience in pharmaceutical 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. Specifically, regulatory requirements of drug-led-device combination (e.g., pre-filled syringes, injectables and ophthalmic products). Knowledge of Canadian and EU Guidelines are a plus.
• Strong knowledge of eCTD elements and structure and regulatory technical writing skills.
• Regulatory experience supporting both development projects and commercial products. Experience in developing injectables and drug-device combination products is essential.
• Experience in ophthalmic products is preferred.
• Experience working with all levels of management and consulting with key internal and external business stakeholders. An ability to influence for 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 Microsoft Office Suite (g., Outlook, Teams, Word, etc.) and other applications (e.g., Adobe Acrobat and eCTD viewers).
• Behavioral and Interpersonal:
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Detail oriented and well organized.
• Independently motivated and solution oriented

Level of Education Required:

• Bachelor of Science in a scientific discipline, advanced degree highly preferred.

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 for Associate Director. For Director, 10 years’ experience in CMC Regulatory Affairs with prior pharmaceutical industry experience.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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