Role: CMC Regulatory Consultant
Location: Summit, NJ
Duration: 6 Months + Extensions
Required Skills & Experience
- 5+ year's experience owning Regulatory Submissions
- Experience within CPG or pharmaceutical industry
- Experience with regulated systems including Documentum, Veeva, etc.
- Strong communication skills
Job Description
Insight Global is looking for a CMC Regulatory Consultant to join the Regulatory Affairs organization within R&D at a Consumer Healthcare organization. This individual will be responsible for authoring, reviewing, and approving regulatory documents and submissions within Module 2 and Module 3. They will review documents for compliance and submission readiness from cross-functional teams, strategize data and documentation best practices, and perform technical writing. The ideal candidate will have a strong end-to-end knowledge of the product lifecycle, regulatory compliance, and technology skills. They will be involved in FDA audits and communication with key stakeholders.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Compensation: $62hr to $72hr
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