Job Description

Daily archiving of regulatory submission documents and health authority correspondence received from CROs, external partners, and Regulatory Affairs leads. Create and/or update eDMS with relevant information to support future search and retrieval of archived submissions and correspondence. Assist with transfer of drug applications / submissions, Health Authority correspondence, and other associated regulatory documents from the regulatory archive, shared drive folders, and off-site storage that are associated with products being transferred or sold to other pharmaceutical companies. Support inspection readiness and preparation activities. Contact and work with internal subject matter experts and/or external partners to determine the completeness of drug application chronologies and/or resolve issues, as needed

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

1. Demonstrated experience in performing the role of a Regulatory Archivist. Archiving drug application submissions, correspondence, and other related regulatory documents in support of a pharmaceutical company

2. Experience with the Veeva Systems Submissions/Archive Vault is highly desirable.

3. Regulatory Drug Application & Submissions Knowledge and experience understand the drug application and electronic submission process, as this assignment can involve knowing where to look to find regulatory materials and who to talk to if you cant

4. Document Management Experience Demonstrated experience in the operation and use of a document management system and, in particular, experience in administering a regulatory archive

5. Communication Skills Performing on this project will require the ability to work with subject matter experts, external partner staff, regulatory and/or commercial management, and possibly IT professionals 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.