Jobs for People with MS: National MS Society

Job Description

Day-to-Day

Insight Global is looking for a Senior Regulatory Affairs CMC Specialist to join the team of a large pharmaceutical company within their animal health products division. This position will be responsible for the development of CMC regulatory submission strategies and timelines for specific drug products. The individual in this role will be spending their time authoring regulatory CMC dossiers for new and existing commercial products along with completing the assessment of change controls. The ideal candidate will have a strong background in regulatory affairs and excellent technical writing skills.

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

Must-haves

• 5+ years' experience within Regulatory Compliance within the pharmaceutical environment

• Experience authoring and reviewing CMC sections for filing

• Experience assessing and reviewing change controls

• API experience (drug manufacturing) 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.