Regulatory Operations eCTD Submission Specialist

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.

This role will provide support to the Regulatory Affairs department ensuring the delivery of timely and high-quality Regulatory submissions for all of EyePoint’s projects.

We are looking for a Regulatory Operations eCTD Submission Specialist to join our team at EyePoint Pharmaceuticals. This role will report to the Senior Director, Regulatory Affairs, and will be based in Watertown, MA. We offer a hybrid work schedule.

Responsibilities

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

Individual responsibilities

• Assist in planning, preparation and submission of eCTD material through to US and ex-US regulatory agencies.
• Support Regulatory Operations and cross-functional teams in the planning, creation and tracking to completion of submission ready documents
• Review documents and edit their formatting and style to meet regulatory guidelines and compliance with departmental SOPs and style guidelines.
• Identify and prepare relevant FDA forms with submissions (e.g. 2253, 356h, 1571 etc)
• Update and maintain trackers for regulatory submissions, correspondence, health authority commitments to ensure all regulatory records are “audit ready”
• Organize and archive new and historic regulatory documents in Microsoft SharePoint, IQVIA RIMSmart and Veeva Vault Submissions Archive
• Contribute to the development and review of Standard Operation Procedures, Work Instructions, and guides relevant to Regulatory Operations
• Provide general administrative support such as updating trackers, taking meeting minutes, other special projects and miscellaneous duties as needed.

Qualifications

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

• Strong knowledge of eCTD structure, ICH standards and submission requirements
• Experience with Publishing, Regulatory Writing and submission through the FDA ESG
• Experience with ex-US submissions (EMA, Health Canada, etc)
• Proficient in the use of Microsoft Office, Adobe Acrobat Pro products and StartingPoint templates
• Excellent written and verbal communication skills including ability to write clearly and present information effectively
• Exceptional organizational skills, and the ability to think critically, independently and problem solve on tight deadlines
• Detail-oriented with the ability to understand the overall strategy of multiple projects/programs

Preferred:

• Experience with multiple cloud-based RIM systems (Veeva, IQVIA RIMSmart, )
• Experience with IND, NDA (including Ad Promo submissions) CTA and MAA submissions.

Level of Education Required:

• BA/BS with experience in the pharmaceutical industry or equivalent

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

• 3 years’ experience in Regulatory Operations/Affairs are required.

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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