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Regulatory Submissions Manager_ Remote
🔒 Direct submission to hiring team • Zero candidate fees
Role & Company Overview
Employer
NEOTECH Solutions
Location / Model
100% Remote
Employment
Contract / Freelance
Recruitment Type
Direct to HR Pipeline
Industry
General
Company Size
Headquarters
United States
Visa & Sponsorship
Global Talent Consideration
📋 Role Overview & Responsibilities
- Job Description · Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.· As a global submissions’ expert, ensure the project team has awareness and knowledge of esubmissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.· Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.· Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.· Manage activities of the publishing vendors in preparation of highquality submission packages and their timely delivery to health agencies.· Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements· Act as a subject matter expert for document management system and support Veeva RIM activities as needed· Compile regulatory submissions.
- Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes.
- Manage submission and product lifecycle information.· Format documents as needed to ensure they are submission ready
Frequently Asked Questions
How do I apply for the Regulatory Submissions Manager_ Remote position at NEOTECH Solutions? ▼
Click the “Apply for this Position” button on this page to submit your application directly to NEOTECH Solutions without recruitment intermediary fees.
Is this position eligible for remote work or visa sponsorship? ▼
Yes, this role is 100% remote and open to qualified professionals worldwide.
Are there any candidate fees on Hirely? ▼
No. Hirely is completely free for candidates. We never charge registration fees or placement fees.
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