Senior Regulatory Affairs Associate

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.