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.

The Senior Manager, Regulatory submissions will be working closely with Regulatory Project Lead(s) develop regulatory submission plans and regulatory affairs systems and tools to further the company’s goals. You will be responsible for timely planning and coordination of regulatory submissions. Create and maintain submission content plans (trackers), ensure administrative forms and documents are current and new guidance is disseminated within the Regulatory Operations group. Final review and sign off of eCTD documents for publishing to health authorities. You will also be expected to remain current in regulatory guidance in the US and select ex-US countries, procedures and practices. You will provide guidance and some oversight to the publishing and submission teams.

This role will report to the Senior Director, Regulatory Affairs. This position is located in Watertown, MA. We offer a hybrid work schedule. Remote candidates will be considered

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

Individual responsibilities

• Responsible for the preparation and execution of eCTD submissions to US and ex-US regulatory authorities (FDA, EMA, Health Canada, etc.) from content plan preparation through electronic submission.
• Establish publishing and submission timelines and ensure that operationally the timelines are met.
• Prepare submission content plans i and Provide advice on regulatory acceptability of submission plans Prepare/review documentation and organize the development of regulatory submissions including but not limited to amendments, marketing applications, advertising / promotion (2253), annual and periodic safety reports.
• Maintain schedule of Periodic Reporting submissions for all relevant regions.
• Coordinate eCTD readiness of documents, assembly of documents per submission content plan and timely submission of initial applications, amendments, supplements and other regulatory filings.
• Work with functional groups to ensure documents are complete and compliant with health authority eCTD or electronic publishing specifications, the company style guide and template specifications.
• Oversee the archival and maintenance of regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements.
• Contribute to improvements in department best practices and SOPs.
• Perform other duties as required, interfacing with other departments, CROs, and other external vendors.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.

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

• Deep knowledge of eCTD elements and structure, ICH standards and submission requirements.
• Experience and knowledge in preparation of CTA’s, INDs, NDAs and supportive amendments and supplements.
• Experience submitting to the FDA electronic submission gateway.
• Experience in web-based content and EDMS/RIM systems (e.g., Veeva, IQVIA RIMSmart)
• Strong regulatory writing and editing skills.
• Proficient in MS-Office Suite and Adobe Acrobat Pro application.
• Ability to balance multiple tasks to meet priorities and timelines.
• Self-starter with superior time management skills, and ability to work independently or in teams.

Preferred:

• Experience submitting eCTD submissions to EMA and Health Canada.
• Knowledge of prescription drug advertising regulations and promotional submissions (FDA Form 2253).
• Experience managing Electronic Document Management Systems (EDMS) and Regulatory Information management System (RIMS).
• Working knowledge of medical devices and drug-device combination US regulations.
• Experience with MS Project and Visio, StartingPoint templates.

Level of Education Required:

• BA/BS degree or equivalent

Number of Years of Experience in the Function and in the Industry:

• At least 6 years experience in Regulatory Operations within the pharmaceutical industry.

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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