Job description
Responsibilities:
Regulatory lead for several pre-IND, IND, and NDA projects, including post-approval submissions
Preparation of Module 1 documents (forms, cover letters, meeting requests, meeting briefing packages, meeting minutes, and other administrative documents) and Module 2.2 _-_ Document preparation includes creation of graphs, flowcharts, and other diagrams
Review and editing of documents which may include quality, nonclinical and clinical documents
Communication with other client personnel and external partners to obtain information needed for submissions and resolve any gaps
Creation and maintenance of project tracking worksheets and project folders in the company network drive and SharePoint
Conduct and scheduling of recurring project meetings and ad hoc meetings
Preparation of meeting slides, monthly reports, and other summaries requested by stakeholders
Archiving of communications (emails, letters, phone calls) from FDA and external partners and recording these communications in a tracker
Research of regulations and guidelines to resolve uncertainties in regulatory strategy General support for client’s Specialty Regulatory Affairs operations
Preparation and maintenance of various tools used by Specialty RA to track the progress of projects (meeting slides, project tracking worksheets, project calendar)
Ad hoc support for projects lead by other client personnel, including document preparation, review and editing, and researching information
Preparation of summaries of new FDA guidance documents
Job Type: Full-time
Pay: $70,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
Schedule:
- 8 hour shift
- Monday to Friday
COVID-19 considerations:
Remote
Application Question(s):
- Please provide your Salary Range Expectations?
Experience:
- Drug Development: 3 years (Required)
- Module 1 & 2.2: 2 years (Required)
- Regulatory Affairs: 5 years (Required)
Work Location: Remote
Speak with the employer
+91 +15515544366
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