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EyePoint Pharmaceuticals, Inc. Regulatory Affairs Associate in Watertown, Massachusetts

See Your Future with EyePoint Pharmaceuticals

We are proud to be named a winner of the 2021 Deloitte Technology Fast 500 award, which recognizes the most innovative, fastest-growing companies in North America. We’re challenging the status quo in bio tech with a singular focus on vision-saving medications delivered through best-in-class proprietary pharmaceutical technologies and unique internal manufacturing capabilities to transform ocular drug delivery.

Our unique culture fosters a science-based entrepreneurial environment, with a collaborative, team-focused approach that embraces diversity, equity and inclusion. Our team’s wellbeing is paramount, which is why we offer comprehensive and highly competitive benefits.

For self-motivated leaders that are passionate about bio pharmaceuticals and ready to make a difference in the lives of patients, EyePoint Pharmaceuticals is a place you can be a catalyst for change and accelerate your career. If you share our vision for preventing blindness and have a passion for bio tech and disruptive change to improve patient care, review the requirements of this opportunity and apply today!

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

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

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

Individual responsibilities

  • Provide administrative support using Microsoft Word, Excel, PowerPoint, Teams, SharePoint, Adobe Acrobat Pro, and other software and systems.

  • Support Regulatory Operations and cross-functional teams in the planning, creation and tracking to completion of submission ready documents

  • Review documents and ensures their formatting and style adheres to appropriate regulatory guidelines and complies with departmental SOPs and style guidelines.

  • Assist in planning and preparation of eCTD submissions with external publishing vendors

  • 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 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 in office managerial tasks such as faxing, updating databases, taking meeting minutes, other special projects and miscellaneous duties as assigned.

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

  • Proficient in the use of Microsoft Office and Adobe Acrobat Pro products

  • Excellent written and verbal communication skills including ability to write clearly and present information effectively

  • Exceptional organizational skills, and the ability to take meeting minutes

  • 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:

  • Basic understanding of the eCTD structure, ICH standards and submission requirements

  • Some experience with Regulatory Operations and Regulatory Writing

  • Working knowledge of Veeva Vault Submissions Archive and Promo Mats

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 is required.

We are an ophthalmology focused company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to improve the lives of patients with serious eye disorders

EyePoint Company Values include:

  • Success begins with our People – our employees are valued, relied upon and key to our company’s success

  • Patient First – above all, we dedicate our skills, actions & resources to achieve quality outcomes for our patients

  • Integrity– we are always honest, open, ethical and fair

  • Results-Driven– we are decisive and act with a sense of urgency against clear and aggressive goals

  • Innovation – we strive for continuous improvement through thoughtful risk-taking

  • Team Focus– we work and communicate in a collaborative, respectful and inclusive fashion

  • Diversity & Inclusion - We commit to diversity in our staff and embrace inclusion and acceptance of others without bias

EyePoint Pharmaceuticals is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

ID: 2022-1247

External Company Name: EyePoint Pharmaceuticals, Inc.

External Company URL: http://eyepointpharma.com/

Street: 480 Pleasant Street

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