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Regulatory Affairs Specialist III
Job Location:
Job Location:
Bridgewater, NJ - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
21 October 2026 (2 days ago)
Posted:
Application Deadline:
18 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title -Regulatory Affairs Specialist III
Location -Bridgewater NJ
Duration - 9 Months
Job Description
Location -Bridgewater NJ
Duration - 9 Months
Job Description
- Manager will consider candidates to be based in either Bridgewater New Jersey or Cambridge Massachusetts. Please specify on resume which location candidate is being submitted for.
- Preparing compiling reviewing and processing the regulatory submissions documents including both pre-approval and submissions such as IND NDA/BLA MAA amendments/supplements annual reports etc.
- Coordinating and consulting with other concerned functions on the content and assembly of regulatory documentation and ensuring consistency completeness and adherence to standards for all the regulatory submissions.
- Assist with regulatory communications with the FDA for assigned products and activities including preparing and formatting of FDA meeting requests briefing book meeting rehearsals/slides meeting minutes of the FDA meetings and the generation of responses to the FDA queries.
- Support the compilation development submission and maintenance of worldwide regulatory filings;
- Track regulatory project status and informational documents
- Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
- Good oral and written communication skills
- Experience with Veeva electronic document management system
- Project management skills including but not limited to creation of timelines organization of meetings meeting minutes demonstrated record of coordinating across stakeholders in a matrixed organization.
- Formatting of Microsoft Word templates
- Familiarity with pharmaceutical regulatory affairs.
Required Experience:
IC
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