We are seeking a Dossier Manager to join a leading global organization in the regulatory sciences industry. This role is essential in managing and publishing key regulatory submissions to Health Authorities, ensuring compliance, accuracy, and timely delivery.
Key Responsibilities:
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Manage the preparation, build, and publishing of regulatory dossiers for global submissions.
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Ensure regulatory submissions comply with Health Authority (HA) requirements (FDA, EMA, etc.).
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Collaborate with cross-functional teams to streamline submission workflows.
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Utilize regulatory publishing software and document management tools to ensure submission accuracy.
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Oversee regulatory compliance obligations, including SUSAR reporting and investigator package coordination.
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Provide expertise on regulatory standards, dossier repurposing, and submission best practices.
Qualifications & Skills:
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Education: B.S. in Pharmacy, Life Sciences, Business, Information Technology, or relevant professional experience.
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Experience:
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Proven expertise in dossier publishing, regulatory compliance, and submission management.
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Strong understanding of FDA, EMA, and global regulatory guidelines.
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Technical Skills:
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Proficiency in Microsoft Office Suite, Veeva Vault, eCTD tools, regulatory publishing software, and document mana...