- 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.
- 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.
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Senior Regulatory Affairs Associate - Berkeley Heights, United States - Breckenridge Pharmaceutical, Inc.
4 days ago
Description
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:
ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE
