20 days old

Manager/Director Regulatory CMC

Oyster Point Pharma
Princeton, New Jersey 08540
  • Job Type
    Employee
  • Job Status
    Full Time
  • 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.

Requirements

  • 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.

Categories

Posted: 2020-02-05 Expires: 2020-03-07

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Manager/Director Regulatory CMC

Oyster Point Pharma
Princeton, New Jersey 08540

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