Associate be responsible for successfully tracking and maintaining various regulatory spreadsheets and databases. With supervision, helps to author, compile, review and submit high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Under supervision, coordinates and writes clear, concise and accurate responses to inquiries from FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files. Works on projects and helps to solve problems where analysis of the situation or data requires evaluation and sound-interpretation of regulatory requirements and/or guidelines.
The Associate, Regulatory Affairs reports into the Manager, Regulatory Affairs and is based in Pine Brook, New Jersey.
Primary responsibilities of this role include the following:
- Accurately update and maintain spreadsheets and databases in a timely manner.
- Prepare Regulatory Affairs weekly updates.
- Will answer and keep a record of any departmental phone calls from regulatory agencies and notify appropriate personnel.
- Prepare work instructions/SOPs and work on potential process optimizations for day-to-day departmental activities.
- With supervision reviews technical documents for accuracy, determines acceptability for use in new ANDAs, NDAs, Amendments, Supplements, Annual Reports and other required FDA filings in order to ensure high-quality submissions and expeditious approvals from FDA.
- Assists in compiling high-quality, original new ANDAs, NDAs, Amendments, Supplements and Annual Reports.
- Assesses changes and their impact to the business based on understanding of regulatory guidelines and applicable federal laws.
- Other duties as assigned.
- Minimum of a Bachelor’s Degree in a life science.
- Minimum of 1 year in the pharmaceutical industry
- Excellent verbal and written communication skills.
- Demonstrates knowledge and understanding of FDA guidelines
- Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
- Strong critical and logical thinker with ability to analyze problems and recommend solutions.
- With direction, effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
- Exercises sound judgement.
- Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
- Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.
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