Sr. Associate, Regulatory Affairs at The Judge Group Inc. in Bedminster, New Jersey

Job Description:

Location: Green Knoll, NJ

Salary: $100,000.00 USD Annually - $110,000.00 USD Annually

Description: Our client is currently seeking a Sr. Associate, Regulatory Affairs who will Independently authors, compiles, reviews, and schedules high-quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Submissions will include: ANDAs, NDAs, 505(b)(2), Amendments, Supplements, and Annual Reports files. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions.




This job will have the following responsibilities:

• Oversee and manage submission compilation while maintaining adherence to FDA standards and internal requirements


• Interact effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions, ensuring that departmental timelines are met.


• Represent regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.


• Independently author, compile, review high-quality, more complex, original new ANDAs, NDAs, Amendments, Supplements, Annual Reports and responses to inquiries from FDA to ensure high-quality submissions and expeditious approvals from FDA.


• Review technical documents for accuracy and acceptability for use in new ANDAs, NDAs, 505(b)(2), Amendments, Supplements, Annual Reports and other required FDA filings.

Qualifications & Requirements:

• Minimum of a Bachelor's Degree in a life science.
• Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.

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Contact: arawat@judge.com


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