Regulatory Affairs Manager
• Publishes and/or manages publishing regulatory submission documents such as INDs, NDAs and IMPDs
• Manages electronic submission activities to meet the company's targeted submission timeline
• Supports to establish an internal electronic submission system and relevant procedures
• Communicates with the e-submission vendor as necessary for an efficient and accurate electronic submission workflow.
• Trains the internal document authors with the e-CTD template
• Checks the submission documents for their accuracy
• Monitors and tracks regulatory trend and newly published regulatory guidelines
• Communicates and collaborates with members from other functions for a timely submission
Qualification, Experience & Education Requirements:
• Electronic document management systems literacy and electronic submission first-hand experience (e-CTD)
• Knowledge of regulatory requirements and guidelines issued by FDA, EMA and ICH
• Recent experience in regulatory submission and approval activities with INDs/NDAs/MAA/DMFs
• Knowledge and experience in regulatory operations, including formatting, publishing, submitting, archiving through document lifecycle
• Computer skills and ability with Microsoft Word, Excel, Access, PowerPoint, Internet Explorer, Documentum, e-room, and etc.
• 5+ years in pharmaceutical regulatory affairs
• Bachelor's degree in a scientific discipline. Advanced degree or Regulatory Affairs Certification is preferred.
Boston Biomedical is an industry leader in the creation and development of next generation cancer theraputics. Our most advanced program involves inhibitors of cancer stem cell pathways. Cancer stem cells have been shown to contribute to both recurrence and metatasis. Because cancer stem cells are thought to be resistant to current chemotherapies, we believe that focusing on stemness pathways may hold promise for advancing cancer treatment. In addition to our advanced cancer stem cell pathway inhibitor program, we have several compounds, which include peptide vaccines and immune response modifiers, in preclinical and early clinical development.
Boston Biomedical is a fully integrated oncology drug research and development company with expertise in drug discovery, crystallography, medicinal chemistry, preclinical development, pharmacology, pharmaceutical development, CMC (chemistry, manufacturing and control), global clinical trials and regulatory affairs. Our scientists have established a track record of accomplishments in a short time, including the discovery and ongoing development of multiple compounds and programs.
As our compounds moved forward in development, we began building out our commercial operations group in 2013.
Boston Biomedical has created a unique corporate work environment. We aim to continue to leverage our innovation-driven culture, scientific leadership and drug development expertise to advance the development of novel cancer therapeutics for patients with cancer.
Tue, 25 Apr 2017 15:28:40 PDT