Manager/Sr. Manager, Regulatory Strategy

divh2Eyepoint Manager/Sr. Manager, Regulatory Strategy/h2pBe seen and heard at EyePoint. Leadership trusts our employees to get the job done. The patient-centric and award-winning approach were taking in business fuels our success for:/pulliPreventing blindness through vision-saving medications/liliDelivering best-in-class proprietary pharmaceutical technologies/liliTransforming ocular drug delivery/li/ulpWe see you./pulliYour wellbeing/liliYour professional worth/liliYour future at EyePoint/li/ulpEyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. Theres 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./ppThe Manager/Sr. Manager, Regulatory Strategy will, under the supervision of the GRL, support day-to-day global regulatory activities for Eyepoints investigational products, and will be a key contributor in the preparation of marketing applications for Eyepoints 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 EyePoints submissions meet global regulatory requirements./ppThis 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./ph2Responsibilities/h2pPrimary responsibilities include, but are not limited to, the following:/pulliAssists 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./liliWorks 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:/liulliReview and proofreading of administrative forms, cover letters, general correspondence for appropriate formatting accuracy, and completeness;/liliauthoring health authority responses alongside subject matter experts/lilicollaborating with cross-functional teams through submission deliverables er submission planning;/lilisupport 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./liliReviewing and proofreading the nonclinical and clinical content of submissions for regulatory acceptability, accuracy and completeness/liliPreparing, Reviewing or proofreading regulatory documents to clinical CROs requested for global clinical trial applications./li/ulliCoordinates with Regulatory operations for submission planning of new applications, supplements or amendments and other regulatory filings in USA and outside US, as appropriate./liliWorks closely with Senior Director, Regulatory Strategy to prepare for US and ex-US regulatory agency meetings./liliMaintains 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/liliContribute as appropriate to authoring of Regulatory Strategy Plan Document, as appropriate/liliContributes to improvements in department best practices and SOPs./liliPerforms other duties as required, interfacing with other departments, CROs, and external vendors/consultants./liliArchives and maintains regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs/li/ulh2Qualifications/h2pPrimary skills and knowledge required include, but are not limited to the following:/pulliExperience and practical knowledge in preparation of INDs, amendments and briefing books./liliFamiliar with the requirements for IBs, clinical protocols and eCTD M1, M2.4, M2.5, M2.6, M2.7, M4 and M5/liliGood working knowledge of FDA requirements for drugs/liliStrong attention to detail and communication skills./liliStrong regulatory writing skills./liliProficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates./liliAbility to balance multiple tasks to meet priorities and timelines./li/ulpPreferred:/pulliNDA preparation, submission and management experience./liliExperience in ophthalmology regulatory submissions/liliExperience with small molecules and drug-led-device combination products./liliExperience in ex-US Clinical Trial Authorization Applications/liliExperience with Regulatory Information Management Systems/li/ulpLevel of Education Required:/pulliBS degree in life or physical sciences./liliMaster of Sciences in Regulatory Affairs is highly desirable./li/ulpNumber of Years of Experience in the Function:/pulliFor Sr. Manager role: Minimum of 4 years regulatory strategy experience within the pharmaceutical industry (or 3 years with a Masters in Regulatory Affairs)/liliFor Manager role: Minimum of 3 years regulatory strategy experience within the pharmaceutical industry (or 2 years with a Masters in Regulatory Affairs)/li/ulpEnvision Your Future/ppWith 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./ppThe collective power of our values influences everything we do, and everything we do for you./ppTransformational Innovation/ppWe 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./ppUnwavering Integrity/ppWe 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./ppCompassionate Excellence/ppWe 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./ppInclusive Collaboration/ppWe strive to see through the eyes of others and work as one team. We appreciate one anothers differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward./ppEyePoint 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./ppEyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoints compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity./ppThe target salary range for this position is listed below./ppMin USD $128,750.00/Yr./ppMax USD $184,713.00/Yr./p/div