Regulatory Affairs Associate
Connecting Talent 2 Opportunity
Job Title
Primary responsibilities of this role include the following:
- Interacts effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions, ensuring that departmental timelines are met.
- Reviews technical documents for accuracy and with supervision, determines acceptability for use in NDAs, Amendments, Supplements, Annual Reports, Health Authority Meeting Requests and Briefing Packages and other required FDA filings in order to ensure high-quality submissions and expeditious approvals from FDA.
- Helps to compile high-quality, original NDAs, Amendments, Supplements, and Annual Reports.
- Assesses changes and their impact on the business based on an understanding of regulatory guidelines and applicable federal laws.
- Other duties as assigned.
Qualifications
- Minimum of a Bachelor's Degree in life science.
- Minimum of 3 years in the pharmaceutical industry with 1-2 of those years in regulatory affairs.
Vacancy posted 20 hours ago
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