Manager/Sr. Manager, Regulatory Strategy

Be Seen and Heard at EyePoint

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.

Responsibilities

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

Individual 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

Qualifications

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

• 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.

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

Level of Education Required:

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

Number of Years of Experience in the Function:

• 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)

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.

Transformational Innovation

We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

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.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.

The target salary range for this position is listed below.

#LI-Hybrid

Min

USD $128,750.00/Yr.

Max

USD $184,713.00/Yr.