Associate Director Regulatory Affairs
Proclinical is in search for an Associate Director to oversee Regulatory Operations manage and track regulatory submissions. You will be expected to provide regulatory operations expertise to cross-functional submission projects teams.
- 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 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.
Skills and Requirements
- 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
- Excellent English Language Skills.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.