Associate Director, International Regulatory Operations
As Associate Director Regulatory Operations, you are responsible for the planning, managing and tracking of regulatory submissions.
Working 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.
This incumbent will also provide regulatory operations expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions.
Here’s What You’ll Do:
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 e‑submissions (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 (BLA, MAA, Variations, 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
Act as a subject matter expert for Moderna document management system.
Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.
Lead and manage special projects as needed.
Here’s What You’ll Bring to the Table:
Bachelor’s degree in a scientific discipline or systems technology or equivalent.
5-8 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 European, EEA, Western Europe, US, and ROW electronic submission standards and industry trends for electronic submission requirements.
Knowledge of SPOR, and IDMP requirements.
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.