Manager/Sr. Manager, Regulatory Strategy

EyePoint Pharmaceuticals, Inc.•Watertown, MA

49d•Hybrid

About The Position

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 Manager/Sr. Manager, Regulatory Strategy will, under the supervision of the GRL, support day-to-day global regulatory activities for Eyepoint’s investigational products, and will be a key contributor in the preparation of marketing applications for Eyepoint’s ophthalmology products. This newly created role includes preparation of Regulatory submissions (including INDs, IND/CTA/amendments, briefing books and NDAs), supporting the team on regulatory filings and responses, and providing critical regulatory intelligence. The (Sr) Manager Regulatory Strategy will participate in cross-functional team meetings and work closely with Regulatory Operations to ensure EyePoint’s submissions meet global regulatory requirements. This position reports to the Senior Director, Regulatory Strategy and will be based in Watertown, MA, with the option of a hybrid work schedule working onsite 3 days per week.

Requirements

Experience and practical knowledge in preparation of INDs, amendments and briefing books.
Familiar with the requirements for IBs, clinical protocols and eCTD M1, M2.4, M2.5, M2.6, M2.7, M4 and M5
Good working knowledge of FDA requirements for drugs
Strong attention to detail and communication skills.
Strong regulatory writing skills.
Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
Ability to balance multiple tasks to meet priorities and timelines.
BS degree in life or physical sciences.
For Sr. Manager role: Minimum of 4 years regulatory strategy experience within the pharmaceutical industry (or 3 years with a Masters in Regulatory Affairs)
For Manager role: Minimum of 3 years regulatory strategy experience within the pharmaceutical industry (or 2 years with a Masters in Regulatory Affairs)

Nice To Haves

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
Master of Sciences in Regulatory Affairs is highly desirable.

Responsibilities

Assists the Senior Director, Regulatory Strategy in implementing regulatory strategy plans, from development and throughout the life-cycle of the dossier/product with the focus on nonclinical and clinical modules.
Works closely and collaboratively with other functions in the preparation of high-quality, timely submissions to Regulatory Agencies. This is a ‘hands on’ position including, as needed:
Review and proofreading of administrative forms, cover letters, general correspondence for appropriate formatting accuracy, and completeness;
authoring health authority responses alongside subject matter experts
collaborating with cross-functional teams through submission deliverables er submission planning;
support of submission activities for initial INDs, NDAs, amendments/supplements, Clinical Trial Applications, meeting requests/briefing materials, and as appropriate, expedited program designation requests and Pediatric Study Plans.
Reviewing and proofreading the nonclinical and clinical content of submissions for regulatory acceptability, accuracy and completeness
Preparing, Reviewing or proofreading regulatory documents to clinical CROs requested for global clinical trial applications.
Coordinates with Regulatory operations for submission planning of new applications, supplements or amendments and other regulatory filings in USA and outside US, as appropriate.
Works closely with Senior Director, Regulatory Strategy to prepare for US and ex-US regulatory agency meetings.
Maintains working knowledge of the regulations and processes that govern the content and maintenance of documents required by the Health Authorities and ICH, and keeps up to date with the regulatory and competitor landscape
Contribute as appropriate to authoring of Regulatory Strategy Plan Document, as appropriate
Contributes to improvements in department best practices and SOPs.
Performs other duties as required, interfacing with other departments, CROs, and external vendors/consultants.
Archives and maintains regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs