Regulatory Content Developer
hace 1 semana
About Us
">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
">- 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
">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
">The estimated salary for this role is $85,000 - $110,000 per year, depending on location and experience.
Benefits
">We offer competitive benefits packages to attract and retain top talent.
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