(Sr) Manager, Regulatory Strategy

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:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

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.

The (Senior) Manager, Regulatory Strategy, will be responsible for day-to-day global regulatory activities for Eyepoint’s investigational products, and will be a key contributor in the preparation and support of marketing applications for Eyepoint’s ophthalmology products. This newly created role includes preparation of Regulatory submissions (including INDs, IND/CTA/amendments, briefing books and NDAs), providing guidance to the team on regulatory filings and responses, and providing critical regulatory intelligence to the program team. The (Sr) Manager Regulatory Strategy will participate in cross-functional team meetings, partner with Subject Matter Experts, and work closely with Regulatory CMC and Regulatory Operations to ensure EyePoint’s submissions meet global regulatory requirements.

This position reports to the Director, Regulatory Strategy and will be based in Watertown, MA, with the option of a hybrid work schedule.

Responsibilities

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

Individual responsibilities

• Assists the Director, Regulatory Strategy in designing and implementing regulatory strategy plans for assigned products/projects, from development and throughout the life-cycle of the dossier/product.
• Works closely and collaboratively with other functions in the preparation of high-quality, timely submissions to Regulatory Agencies. This is a ‘hands on’ position including, as needed:
• review of administrative forms, cover letters, general correspondence;
• authoring health authority responses alongside subject matter experts
• working with cross-functional teams through submission deliverables;
• support of submission activities for initial INDs, NDAs, amendments/supplements, Clinical Trial Applications, meeting requests/briefing materials, and as appropriate, expedited program designation requests and Pediatric Study Plans.
• Reviewing the nonclinical and clinical content of submissions for regulatory acceptability.
• Coordinates with Regulatory operations and Regulatory CMC for submission planning of new applications, supplements or amendments and other regulatory filings in USA and outside US, as appropriate.
• Works closely with Director, Regulatory Strategy to prepare for US and ex-US regulatory agency meetings.
• Maintains working knowledge of the regulations and processes that govern the content and maintenance of documents required by the Health Authorities and ICH, and keeps up to date with the regulatory and competitor landscape
• Contributes to improvements in department best practices and SOPs.
• Performs other duties as required, interfacing with other departments, CROs, and external vendors/consultants.
• Archives and maintains regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs.

Qualifications

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

• Experience and knowledge in preparation of INDs, supportive amendments or supplements and briefing books.
• NDA preparation, submission and management experience.
• Working knowledge of eCTD elements and structure, ICH standards and submission requirements.
• Strong communication skills.
• Strong regulatory writing skills.
• Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
• Ability to balance multiple tasks to meet priorities and timelines.

Preferred:

• Experience in ophthalmology regulatory submissions
• Experience with small molecules and drug-led-device combination products.
• Experience in ex-US Clinical Trial Authorization Applications
• Experience with eCTD and using Regulatory Information Management Systems

Level of Education Required:

• BS degree in life or physical sciences.
• Master of Sciences in Regulatory Affairs is highly desirable.

Number of Years of Experience in the Function:

• For Senior Manager role:
• For Manager role: Minimum of 4 years regulatory strategy experience within the pharmaceutical industry (or 3 years with a Masters in Regulatory Affairs)

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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