Regulatory submissions:
Primary responsibilities include the preparation of ANDAs, Supplements, Annual Reports and responses to FDA review letters/requests for additional information in support of existing products. Actively participate in the Company's project management system, submission compilation team meetings and department meetings. Provide suggestions that could lead to an improvement in the overall submission process. Retrieve, review, and collate all supporting documentation for FDA submissions in a timely manner. Prepare submissions on project management basis, and carry projects through to FDA approval.
Other documents review:
Review master formula, stability protocols, and other related documents for accuracy and regulatory acceptability.
Change controls:
Review and approve/disapprove change controls in QUMAS and Trackwise associated with assigned projects and provide regulatory comments and required documents as applicable.
Communications:
Communicate and provide regulatory guidance to various Project Teams in connection with the assigned projects. Keep RA Manager or Director informed of any activities/issues/decisions that may impact the quality or the timeline of submission of any project.
Other responsibility:
Work independently with minimal supervision. Conduct review of submissions prepared by other Associates as directed by RA Manager or Director.
Education: BS or MS degree in scientific field such as Pharmacy, Chemistry, Biology, etc.
Experience: 2 years in Regulatory Affairs in generic Pharmaceutical Industry, or 2-4 years exposure in Pharmaceutical filed such as Analytical, Products Development or Manufacturing.
Primary responsibilities include the preparation of ANDAs, Supplements, Annual Reports and responses to FDA review letters/requests for additional information in support of existing products. Actively participate in the Company's project management system, submission compilation team meetings and department meetings. Provide suggestions that could lead to an improvement in the overall submission process. Retrieve, review, and collate all supporting documentation for FDA submissions in a timely manner. Prepare submissions on project management basis, and carry projects through to FDA approval.
Other documents review:
Review master formula, stability protocols, and other related documents for accuracy and regulatory acceptability.
Change controls:
Review and approve/disapprove change controls in QUMAS and Trackwise associated with assigned projects and provide regulatory comments and required documents as applicable.
Communications:
Communicate and provide regulatory guidance to various Project Teams in connection with the assigned projects. Keep RA Manager or Director informed of any activities/issues/decisions that may impact the quality or the timeline of submission of any project.
Other responsibility:
Work independently with minimal supervision. Conduct review of submissions prepared by other Associates as directed by RA Manager or Director.
Education: BS or MS degree in scientific field such as Pharmacy, Chemistry, Biology, etc.
Experience: 2 years in Regulatory Affairs in generic Pharmaceutical Industry, or 2-4 years exposure in Pharmaceutical filed such as Analytical, Products Development or Manufacturing.