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Regulatory Affairs Associate Manager
2 months ago
Regulatory Affairs Associate Manager/Manager - Hybrid Role
Barrington James is collaborating with a leading global pharmaceutical organization dedicated to advancing generic medications across various formulations and dosage forms. The company is expanding its operations and is in search of a Regulatory Associate Manager or Manager to contribute to its innovative projects. This position is hybrid, requiring presence in New Jersey for 2-3 days a week, providing an excellent opportunity to engage in a variety of regulatory initiatives.
Key Responsibilities:
- Serve as the primary Regulatory Affairs representative for designated projects, ensuring the thoroughness, precision, and quality of eCTD submissions, including ANDAs, Supplements, Amendments, and Annual Reports.
- Regularly update senior management in Regulatory Affairs on significant project milestones and their implications for regulatory submissions, addressing any potential challenges that may emerge during FDA evaluations.
- Collaborate with various internal stakeholders to gather necessary documentation for regulatory submissions, ensuring adherence to departmental timelines.
- Assist in the formulation and assessment of technical documents for compliance and suitability for new ANDAs, Amendments, Supplements, Annual Reports, and other essential FDA filings, aiming for high-quality submissions and timely FDA approvals.
- Evaluate and authorize change controls, analyzing 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; advanced degrees in Manufacturing, Chemical, Pharmaceutical, or Biological Sciences are advantageous. (RAC Certification is preferred)
- Experience: At least 4 years of experience in the generic pharmaceutical sector, with a minimum of 3 years focused on Regulatory Affairs.
- Knowledge: Familiarity with standard practices in Regulatory Affairs for generic pharmaceuticals and FDA regulations.
- Travel Requirements: Minimal travel (approximately 5%), which may include international visits to manufacturing facilities or contract research organizations.
Explore this opportunity to enhance your career in regulatory affairs within a dynamic and growing company.
