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Senior CMC Regulatory Specialist_

3 months ago

Rahway, United States Insight Global Full time

Job Description Insight Global is looking for a Senior CMC Regulatory Specialist to join the Global Regulatory Affairs organization with a large pharmaceutical company. This role will be supporting various ongoing regulatory projects for various products globally. This individual will be responsible for developing CMC regulatory strategies and authoring various regulatory CMC submissions including dossiers, variations, and supplements. This role will also have responsibility over product license renewals and expansions. The ideal candidate will have strong communication skills with the ability to drive conversations with cross-functional teams to deliver on assigned regulatory milestones. This will be a 12 month contract to start and expectation of onsite presence in New Jersey location 3 times per week. 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: om/workforce-privacy-policy/ . Skills and Requirements - 5+ years experience in Regulatory Affairs within pharmaceutical industry - Extensive experience with authoring CMC submissions (dossiers, supplements, variations, etc) - API Experience 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 HR@insightglobal.com.