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Job Responsibilities:
- Oversee submission execution activities, including tracking deliverables, coordinating timelines, and assessing submission readiness.
- Collaborate with Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve publishing and documentation challenges.
- Provide technical guidance to authoring teams regarding document templates, formatting standards, and publishing requirements.
Qualifications:
- Bachelor’s degree with at least 4 years of experience in Regulatory Operations or a related regulatory function.
- Demonstrated expertise in regulatory document preparation, formatting, PDF publishing, and submission management.
- Strong understanding of eCTD submission structures, PDF specifications, bookmarks, hyperlinks, file naming conventions, and regulatory publishing standards.
Compensation & Benefits:
- Competitive annual salary range of approximately $134,505 - $162,988 USD, depending on skills, experience, location, and other job-related factors.
- Comprehensive health coverage, including medical, pharmacy, dental, and vision plans.
- Retirement benefits, including a 401(k) plan, financial protection programs, paid time off, and additional leave programs.
Jobgether
This company specializes in regulatory operations and publishing for innovative healthcare solutions. The team operates in a fast-paced life sciences environment with a collaborative and multidisciplinary approach.