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EyePoint · 1 day ago

Manager/Sr. Manager, Regulatory Strategy

Watertown, MA

Full-time

Hybrid

Mid, Senior Level

$129K/yr - $185K/yr

3+ years exp

EyePoint is an ophthalmology company committed to preventing blindness through innovative therapeutics. The Manager/Sr. Manager, Regulatory Strategy will support global regulatory activities for investigational products and prepare marketing applications, ensuring compliance with regulatory requirements.

BiotechnologyHealth CareMedicalPharmaceutical

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

Qualification

IND preparationRegulatory writingFDA requirementsNDA preparationOphthalmology submissionsECTD knowledgeMS Word proficiencyAdobe Acrobat ProMulti-taskingAttention to detailCommunication skills

Required

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)

Preferred

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

Company

EyePoint

EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of people with serious retinal diseases.

Founded in 1987

Watertown, Massachusetts, USA

51-200 employees