Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

JOB SUMMARY:

The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. A Senior Associate is expected to have a strong understanding of ANDA requirements and demonstrate that knowledge through interactions with partners and in writing/compiling more complex submissions.

DUTIES AND RESPONSIBILITIES:

• Support pre-approved applications by compiling and authoring complex amendments and original submissions using BPI templates.
• Under supervision of Regulatory Management, manage post-approval project submissions, including, but not limited to, site transfers, alternate source submissions, analytical changes, container/closure changes, annuals reports and periodic adverse event reports (when applicable).
• Evaluate proposed changes to applications versus current available guidance documents and formulate filing strategies.
• Interact with BPI partners to facilitate documentation review/exchange, advance project activities and attend project team meetings in absence of the Regulatory Project Lead, as needed.
• Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations
• Support new product launches by filing PLAIR, providing regulatory guidance and ANDA/Supplement approval status, labeling, and drug listing.
• Provide guidance to partners regarding content of technical/regulatory/clinical documentation.
• Proficiency in all tasks outlined for Regulatory Associate.

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

• Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software.
• Experience with ANDA writing and compilation
• BS Required (preferably in a science –Biology, Chemistry or Pharmacy); graduate degree a plus.
• Minimum 3 years’ experience in pharmaceutical regulatory, quality or product development operations.
• Familiar with cGMP/cGCP requirements.
• Required to attend off-hours teleconferences with overseas partners.