May 19, 2021

Associate Director, Regulatory Affairs – CMC

  • Oyster Point Pharma
  • Princeton, New Jersey
Regulatory

Job Description

Oyster Point Pharma, Inc. (OYST: Nasdaq) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Headquartered in Princeton, New Jersey, with an anticipated satellite office in Boston, Massachusetts, Oyster Point filed its first New Drug Application in Q4’ 2020 with an anticipated product launch in Q4’ 2021. This is an exciting time to join Oyster Point as it prepares to transition from a clinical stage company to a commercial enterprise. SUMMARY: The Associate Director, Regulatory Affairs – CMC will be responsible for managing regulatory CMC submissions of Oyster Point Pharma’s products throughout their lifecycle. The Associate Director is responsible for submissions for products under his/her responsibility. Primary Responsibilities: Prepare/coordinate/file/manage the CMC eCTD content of IND/CTAs, NDA, annual reports, and information amendments for global submission. Participate in the preparation and filing of the regulatory applications (IND/CTA, NDA/BLA/MAA). Participate in the preparation of responses to questions from Regulatory Authorities. Interface with functional areas to identify and obtain information required for regulatory submissions. Develop and/or review regulatory documents to ensure that all submissions are of high quality. Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met. Support regulatory filings and applications, including preparation and coordination of briefing packages. Provide critical review of documents (SOPs, protocols, and reports) related to manufacturing, as necessary. Review and provide regulatory assessment to proposed CMC changes. Maintain knowledge of current global rules, regulations, and guidance governing development of drugs and biologics in all phases of development. Required Skills: Thorough understanding of global drug manufacturing regulations and guidelines. Excellent CMC technical writing and communications skills with strong background in small molecule pharmaceutical development, manufacturing, and regulatory writing. Experience in addressing CMC-related regulatory queries from global health authorities. Proven ability to successfully manage major submissions and critical projects to deadlines. Excellent attention to detail, and strong computer and organizational skills required. Strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills. Other Requirements: BS or higher in a scientific field. At least 5 years’ experience in CMC Regulatory Affairs in the biotechnology or pharmaceutical industries. Biologics experience a plus.

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