Regulatory Affairs Specialist (1 Year Contract) - EyePoint Pharmaceuticals, Inc.

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 Regulatory Affairs specialist will be working under the supervision of the Director of Regulatory Strategy to perform operational tasks related to clinical trial applications and IND activities such as:

• Review of country adaptations of documents (in English) against approved master documents to ensure consistency and accuracy
• Tracking of documents/ submissions
• Administrative support in answering regulatory queries

This role will report to the Director, Regulatory Strategy. This is a one-year contract.

This position is located at our Watertown, MA site. We offer a hybrid work schedule.

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

Individual responsibilities

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

• Under supervision of Regulatory Strategy Director, prepare and check documents for IND clinical amendments  for accuracy and completeness
• Review of country adaptations of documents (in English) against approved master documents to ensure consistency and accuracy
• Tracking of documents/ submissions
• Administrative support in answering regulatory queries

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

• Excellent attention to details
• Organization skills
• Collaborative team player
• Strong knowledge of using MS Word
• 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.

 Level of Education Required:

• BA/BS degree or equivalent

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

1-3 years’ experience in the biotech/pharma industry of which at least 1 year drug regulatory affairs or supporting clinical operations

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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