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Regulatory Affairs Associate Manager

2 months ago

New York, New York, United States Barrington James Full time

Regulatory Affairs Associate Manager/Manager - Hybrid Role

We are collaborating with a prominent global pharmaceutical organization dedicated to the development and distribution of generic medications across various formulations and dosage forms. The company is in a phase of growth and is looking for a Regulatory Associate Manager or Manager to enhance their team. This position offers a hybrid work model based in New Jersey, requiring onsite presence 2-3 days a week, and presents an excellent opportunity to engage in a variety of projects.

Key Responsibilities:

  • Serve as the primary Regulatory Affairs representative for designated projects, ensuring the thoroughness, precision, and content of eCTD submissions, including ANDAs, Supplements, Amendments, and Annual Reports.
  • Keep senior Regulatory Affairs management informed about critical project updates and their potential implications for regulatory submissions, identifying any challenges or issues that may arise during FDA evaluations.
  • Collaborate with various stakeholders within the organization to gather necessary documentation for regulatory submissions, ensuring adherence to departmental timelines.
  • Assist in the creation and review of technical documents to guarantee their accuracy and compliance for new ANDAs, Amendments, Supplements, Annual Reports, and other essential FDA filings, aiming for high-quality submissions and timely approvals from the FDA.
  • Evaluate and authorize change controls, assessing their impact on the business based on a comprehensive understanding of regulatory standards and applicable FDA regulations.

Qualifications:

  • Education: A minimum of a bachelor’s degree in a life science or pharmacy-related field, with an advanced degree in Manufacturing, Chemical, Pharmaceutical, or Biological Sciences being advantageous. (RAC Certification is a plus)
  • Experience: At least 4 years of experience in the generic pharmaceutical sector, with a minimum of 3 years specifically in Regulatory Affairs.
  • Knowledge: Familiarity with general practices in Regulatory Affairs for generic pharmaceuticals and FDA regulations.
  • Travel Requirements: Minimal travel (approximately 5%), with potential international travel to manufacturing sites or contract research organizations.

This position offers a unique opportunity to contribute to the regulatory landscape of a dynamic pharmaceutical company.