Submission Manager, Regulatory OperationsApply Now
Location: , Massachusetts 02139
Employment Type: Contract
Contract Length: 6+ months
Job Summary: The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner.
- 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 high-quality submission packages and their timely delivery to health agencies.
- Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements
- Bachelor’s degree in a scientific discipline or systems technology or equivalent
- 4-6 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)
- Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
- Extensive knowledge of North American/Global submission standards (FDA, Health
- Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.)
- Knowledge of CDISC (ADaM, SEND, SDTM)
- A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)
- Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.
- MS PowerPoint skills
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