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Advanced Regulatory Affairs Consultant
2 months ago
Breckenridge Pharmaceutical Inc. is dedicated to the development and marketing of high-quality, value-added, and cost-efficient generic medications in the United States. Our products are innovatively developed within our own research and development facilities and through strategic collaborations with manufacturers globally.
POSITION SUMMARY:
The Senior Compliance Affairs Officer plays a crucial role in supporting applications under both pre-approval and post-approval conditions. 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 more intricate submissions.
KEY RESPONSIBILITIES:
- Assist in pre-approval applications by drafting and compiling complex 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 applicable.
- 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 initiatives, and attend project team meetings in the absence of the Regulatory Project Lead, as necessary.
- 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 submitting PLAIR, offering regulatory guidance, and providing updates on ANDA/Supplement approval status, labeling, and drug listing.
- Offer advice to partners regarding the content of technical, regulatory, and clinical documentation.
- Demonstrate proficiency in all tasks designated for Regulatory Associates.
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.
