• CMC Regulatory Consultant

    Insight Global (Summit, NJ)


    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 inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

     

    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/ .

     

    Skills and Requirements

     

    - 5+ year's experience owning Regulatory Submissions

     

    - Experience within CPG or pharmaceutical industry

     

    - Experience with regulated systems including Documentum, Veeva, etc.

    - Strong communication skills null

    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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].