Manager​/Sr. Manager, Regulatory Strategy

Manager/Sr. Manager, Regulatory Strategy

On‑site 3 days per week at our Watertown, MA office, or hybrid work schedule (3 onsite days).

• Assist the Senior Director, Regulatory Strategy in implementing regulatory strategy plans from development through the life‑cycle of the dossier/product, focusing on non‑clinical and clinical modules.
• Collaborate closely with other functional teams to prepare high‑quality, timely submissions to regulatory agencies, including:
  • Review and proofreading of administrative forms, cover letters and correspondence for accuracy and completeness.
  • Authoring health‑authority responses together with subject‑matter experts.
  • Co‑ordinating cross‑functional teams through submission deliverables and planning.
  • Supporting submission activities for initial INDs, NDAs, amendments/supplements, clinical trial applications, meeting requests, briefing materials, expedited designation requests and pediatric study plans.
  • Reviewing non‑clinical and clinical content for regulatory acceptability, accuracy and completeness.
  • Preparing, reviewing or proofreading regulatory documents requested for global clinical trial applications with CROs.
• Coordinate with Regulatory Operations for submission planning of new applications, supplements or amendments in the US and abroad.
• Work closely with the Senior Director, Regulatory Strategy to prepare for US and ex‑US regulatory agency meetings.
• Maintain working knowledge of regulations and processes governing content and maintenance of documents required by health authorities and ICH, and keep up‑to‑date with regulatory and competitive landscapes.
• Contribute to authoring of regulatory strategy plan documents and improvements in departmental best practices and SOPs.
• Perform other duties as required, interfacing with other departments, CROs, and external vendors/consultants.
• Archive and maintain regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs.

• Experience and practical knowledge in preparation of INDs, amendments and briefing books.
• Familiar with IBs, clinical protocols and eCTD levels M1, M2.4, M2.5, M2.6, M2.7, M4, M5.
• Good working knowledge of FDA requirements for drugs.
• Strong attention to detail and communication skills.
• Strong regulatory writing skills.
• Proficiency in MS Word, Adobe Acrobat Pro and eCTD template use.
• 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 in ex‑US clinical trial authorization applications.
• Experience with regulatory information management systems.

• BS degree in life or physical sciences.
• Master of Science in Regulatory Affairs is highly desirable.

• For Sr. Manager role:
  Minimum 4 years regulatory strategy experience within the pharmaceutical industry (or 3 years with a Master’s in Regulatory Affairs).
• For Manager role:
  Minimum 3 years regulatory strategy experience within the pharmaceutical industry (or 2 years with a Master’s in Regulatory Affairs).

Min: USD $ / yr
Max: USD $ / yr

EyePoint 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.