Regulatory Affairs Associate Manager

2 weeks ago

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

Regulatory Affairs Associate Manager/Manager - Hybrid Role

We are currently collaborating with a leading global pharmaceutical organization dedicated to the development and market introduction of generic medications across various formulations and dosage forms. This expanding company is looking for an Associate Manager or Manager to enhance their Regulatory Affairs team. This position offers a hybrid work arrangement based in New Jersey, requiring 2-3 days of onsite presence.

Key Responsibilities:

  • Serve as the primary Regulatory Affairs representative for designated projects, ensuring the precision and thoroughness of eCTD submissions, including ANDAs, amendments, supplements, and annual reports.
  • Keep senior Regulatory Affairs management informed about significant project developments and their implications for regulatory submissions, addressing any potential challenges that may arise during FDA evaluations.
  • Engage with various stakeholders within the organization to gather necessary documentation for regulatory submissions, ensuring adherence to departmental timelines.
  • Assist in the creation and evaluation of technical documents to guarantee their accuracy and compliance for new ANDAs, amendments, supplements, annual reports, and other required FDA filings, facilitating high-quality submissions and timely approvals.
  • Review and authorize change controls, evaluating their impact on business operations 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 medications and FDA regulations.
  • Travel Requirements: Minimal travel (approximately 5%), which may include international visits to manufacturing sites or contract research organizations.

This role presents an exciting opportunity to contribute to the regulatory landscape of generic pharmaceuticals.

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