Amneal Pharmaceuticals
Description:
The Regulatory Affairs Specialist assists in the preparation, review and submission of high quality, regulatory submissions such to the Food and Drug Administration (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws.
Essential Functions:
The Regulatory Affairs Specialist, assists in the management of regulatory submissions to (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. This may include but it is not limited to New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (IND), Biologics License Applications (BLA), Marketing Authorizations (MA), Post-Approval Supplements, Annual Reports (AR), Periodic Adverse Drug Experience Report (PADER), Controlled Correspondences (CC) and End-User Letters (EUL).
Assists in tracking and managing the status of submissions under review with FDA as per the Generic Drug User Fee Amendments (GDUFA) requirements. Ensures that internal tracking systems are always up to date. This includes relevant databases in the Amneal Application Suite and well as internal trackers and PowerPoint presentations for management meetings.
Assists in tracking the committed timeliness and follows up with the internal departments for required documents. Coordinates with external vendors, contractors and consultants for project support activities. This may include but is not limited to: US Agent Letters, and other certifications/statements required by FDA and other Health Authorities.
Assists in organizing meetings with FDA or other Health Authorities, including submitting the meeting requests, setting up internal preparation meetings, assist meeting leads in preparing presentations and talking points, and type-up meeting minutes.
Organizes and maintains submission components associated with electronic submissions. This may include scanning, converting to PDF, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress in coordination with Regulatory Operations Department.
Additional Responsibilities:
Gains knowledge in the use of e-CTD structures for submissions.
Works with colleagues in resolving regulatory issues and/or problems.
Archives and maintains all submissions in a systematic way.
Performs administrative functions as directed by management to support projects and to ensure the smooth operation of the department.
Maintains current knowledge of regulations and other issues that affect products and industry.
Ensures that information from FDA and other Health Authorities is disseminated internally as required.
The Regulatory Affairs Specialist assists in the preparation, review and submission of high quality, regulatory submissions such to the Food and Drug Administration (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws.
Essential Functions:
The Regulatory Affairs Specialist, assists in the management of regulatory submissions to (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. This may include but it is not limited to New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (IND), Biologics License Applications (BLA), Marketing Authorizations (MA), Post-Approval Supplements, Annual Reports (AR), Periodic Adverse Drug Experience Report (PADER), Controlled Correspondences (CC) and End-User Letters (EUL).
Assists in tracking and managing the status of submissions under review with FDA as per the Generic Drug User Fee Amendments (GDUFA) requirements. Ensures that internal tracking systems are always up to date. This includes relevant databases in the Amneal Application Suite and well as internal trackers and PowerPoint presentations for management meetings.
Assists in tracking the committed timeliness and follows up with the internal departments for required documents. Coordinates with external vendors, contractors and consultants for project support activities. This may include but is not limited to: US Agent Letters, and other certifications/statements required by FDA and other Health Authorities.
Assists in organizing meetings with FDA or other Health Authorities, including submitting the meeting requests, setting up internal preparation meetings, assist meeting leads in preparing presentations and talking points, and type-up meeting minutes.
Organizes and maintains submission components associated with electronic submissions. This may include scanning, converting to PDF, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress in coordination with Regulatory Operations Department.
Additional Responsibilities:
Gains knowledge in the use of e-CTD structures for submissions.
Works with colleagues in resolving regulatory issues and/or problems.
Archives and maintains all submissions in a systematic way.
Performs administrative functions as directed by management to support projects and to ensure the smooth operation of the department.
Maintains current knowledge of regulations and other issues that affect products and industry.
Ensures that information from FDA and other Health Authorities is disseminated internally as required.