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.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
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
Benefit packages for this role will start on the 1st 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.