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Advanced Regulatory Affairs Consultant

2 months ago

Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Full time

Senior Regulatory Affairs Associate

Breckenridge Pharmaceutical stands as a prominent entity in the development and marketing of high-quality generic medications across the United States. Our mission is to deliver economical solutions through our dedicated research and development facilities alongside strategic collaborations.

Position Overview:

  • Prepare and draft intricate amendments and submissions for pre-approved applications.
  • Oversee post-approval project submissions, which include site transfers and analytical modifications.
  • Assess proposed alterations to applications and devise filing strategies accordingly.
  • Engage with partners to facilitate project activities and participate in meetings as required.
  • Contribute to drug development while ensuring adherence to regulatory standards.
  • Assist in new product introductions by providing regulatory guidance and necessary documentation.
  • Offer expertise regarding technical documentation.

Required Qualifications:

  • Proficient in eCTD software, MS Word, and various document processing tools.
  • Experience in ANDA writing and compilation.
  • Bachelor's degree in a scientific discipline; advanced degree is advantageous.
  • A minimum of 3 years' experience in pharmaceutical regulatory operations.
  • Familiarity with current Good Manufacturing Practices (cGMP).
  • Willingness to participate in off-hours teleconferences.