Manager​/Sr. Manager, Regulatory Strategy

Manager/Sr. Manager, Regulatory Strategy

Join to apply for the Manager/Sr. Manager, Regulatory Strategy role at EyePoint.

We are a patient‑centric, award‑winning ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

• Assists the Senior Director in implementing regulatory strategy plans across the life‑cycle of investigational products.
• Prepares, reviews, and proofs regulatory documents for INDs, NDAs, amendments, and clinical trial applications.
• Collaborates with cross‑functional teams to ensure high‑quality, timely submissions to regulatory agencies.
• Coordinates submission planning and maintains regulatory filing records in compliance with SOPs.
• Participates in global regulatory agency meetings and provides regulatory intelligence.
• Contributes to regulatory strategy plan documents and improves department best practices.

• Experience preparing INDs, NDA submissions, and briefing books.
• Knowledge of ICH eCTD requirements and FDA regulatory processes.
• Strong regulatory writing and attention to detail.
• Proficiency in MS Word, Adobe Acrobat Pro, and eCTD templates.
• Ability to balance multiple tasks to meet priorities and timelines.

• NDA preparation, submission and management experience.
• Experience in ophthalmology regulatory submissions.
• Experience with small molecules and drug‑led‑device combination products.
• Experience with Regulatory Information Management Systems.

• BS degree in life or physical sciences (Master of Science in Regulatory Affairs highly desirable).
• Minimum of 4 years regulatory strategy experience within the pharmaceutical industry (3 years with a Master’s in Regulatory Affairs).

Target salary range: USD $ – USD $ per year.

EyePoint is proud to be an equal opportunity employer. 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.