Associate Principal Scientist, Global Regulatory and CMC

Job Description

Insight Global is looking for an Associate Principal Scientist, Global Regulatory Affairs CMC to join the Global R&D organization of a large pharmaceutical company. This individual will be responsible for assessing change controls while reviewing technical documentation and scientific information. The Associate Principal Scientist will spend the majority of their time preparing regulatory CMC variations and supplements including technical writing of various CMC sections. This role will be cross-functional to R&D and other regulatory teams. The ideal candidate will have a strong background in API drug development and method development.

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 .

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Skills and Requirements

– Bachelors Degree in Scientific Field, PhD preferred

– 5 years experience in Drug Development

– 2 years experience with technical writing of CMC sections

– 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 HR@insightglobal.com.