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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