Dossier Manager

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:

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 management systems.

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Ability to manage multiple highly complex projects simultaneously.

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Soft Skills:

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Strong attention to detail, project management, problem-solving, and stakeholder communication.

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Ability to work in a fast-paced, deadline-driven, and highly regulated environment.

Why Join Us?

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Work on high-impact regulatory submissions with a leading global team.

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Opportunity to collaborate with top professionals in regulatory affairs.

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Gain hands-on experience with cutting-edge regulatory technologies.

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Competitive salary, benefits, and professional growth opportunities.

If you have the skills and experience to thrive in this role, we’d love to hear from you! Apply today to be part of a dynamic and forward-thinking regulatory team