Regulatory Content Developer

hace 1 semana


Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

About Us

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At ProductLife Group, we strive to excel in the regulatory publishing landscape. Our commitment to delivering top-notch services is reflected in our dedication to ensuring timely and compliant submissions.

Job Description

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  • We are seeking an experienced Regulatory Publisher to manage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission to regulatory authorities (FDA/HC).
  • This role involves quality control procedures to guarantee completion, correctness, navigability, and adherence to regulatory guidelines.
  • The successful candidate will perform document management tasks, including file transfer, tracking, database updates, and archival.
  • Maintaining current knowledge of FDA, HC, and ICH requirements for regulatory submissions is essential for compliance.
  • Collaboration with global functional areas is required to ensure submission-related deliverables meet strategic business objectives.

Required Skills and Qualifications

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Our ideal candidate holds a Bachelor's degree in Life Sciences or a related field and possesses 6 months to 2 years of job experience.

A strong understanding of PowerPoint, Microsoft, and computer-related activities is necessary for this position.

Compensation

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The estimated salary for this role is $85,000 - $110,000 per year, depending on location and experience.

Benefits

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We offer competitive benefits packages to attract and retain top talent.


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