Lead Regulatory Affairs Specialist

2 weeks ago

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

Company Overview:

Breckenridge Pharmaceutical is dedicated to the development and marketing of high-quality, value-added, and economical generic medications within the United States. Our products are crafted in our own research and development facilities and through strategic collaborations with manufacturers globally.

POSITION SUMMARY:

The Senior Associate in Regulatory Affairs plays a crucial role in supporting applications throughout both pre-approval and post-approval phases. This position requires a comprehensive understanding of ANDA regulations and the ability to effectively communicate this knowledge through interactions with partners and in the preparation of complex submissions.

KEY RESPONSIBILITIES:

  • Assist in pre-approval applications by compiling and authoring intricate amendments and original submissions utilizing BPI templates.
  • Under the guidance of Regulatory Management, oversee post-approval project submissions, which may include site transfers, alternative source submissions, analytical modifications, container/closure adjustments, annual reports, and periodic adverse event reports as necessary.
  • Assess proposed modifications to applications against current guidance documents and develop filing strategies accordingly.
  • Collaborate with BPI partners to facilitate the review and exchange of documentation, advance project activities, and attend project team meetings in the absence of the Regulatory Project Lead, as required.
  • Contribute to drug development from early stages through final formulation under the direction of Regulatory Affairs management, ensuring adherence to Quality-by-Design principles, cGMP, and FDA regulations.
  • Support the launch of new products by filing PLAIR, offering regulatory guidance, and providing updates on ANDA/Supplement approval status, labeling, and drug listing.
  • Advise partners on the content of technical, regulatory, and clinical documentation.
  • Exhibit proficiency in all tasks designated for a Regulatory Associate.

ESSENTIAL QUALIFICATIONS, EDUCATION, AND EXPERIENCE:

  • Proficient in eCTD software, MS Word, Excel, Adobe Acrobat, and other document processing tools.
  • Experience in ANDA writing and compilation.
  • Bachelor's degree required (preferably in a scientific field such as Biology, Chemistry, or Pharmacy); a graduate degree is advantageous.
  • A minimum of 3 years of experience in pharmaceutical regulatory, quality, or product development operations.
  • Familiarity with cGMP/cGCP standards.
  • Willingness to participate in off-hours teleconferences with international partners.

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