full time legal management

Job Details

Company Description

Bio-Tech

Job Description

Remote OR may sit at any client site, manager works in EST but open to candidates in different time zones

Title: Regulatory CMC Manager

Job Description: Assist in the development of module 3 templates that will enable population by automation tools, and enable structured content management. Knowledge of the Common Technical Document (CTD), such as Module 3 for regulatory documents such as CMC related sections. Must have some knowledge of CMC and structured content. Be prepared to work within data systems and processes related to regulatory submissions. Working with cross collaborative teams and CMC authoring.

IT experience/programming experience in context of CMC/Module 3 a plus

Qualifications

Top 3 Must Have Skill Sets:

Bachelors Degree in Science/Engineering/IT

6+ years of regulatory experience
Common Technical Document (CTD) knowledge such as Molule 3 (CMC)
data systems and processes related to regulatory submissions

Ideal... candidate: Previous client experience, Systems knowledge, programming experience

Additional Information

All your information will be kept confidential according to EEO guidelines

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