Remote working opportunity!
My client is a global consulting company that provides different solutions for companies in the life science industry They are currently looking for an Associate Consultant to join their team.
Responsibilities:
- Manage and coordinate global submission documentation across new and existing accounts, ensuring all deliverables meet customer expectations.
- Lead or participate in Regulatory Information Management or Systems projects related to global submission documentation.
- Collaborate with partners, subject matter experts, and industry specialists to address customer business requirements and needs.
- Provide global expertise on electronic document management, submission planning, report publishing, and eCTD compilation, including translation of submission requirements between Japanese and English.
- Oversee project management and quality control for regional Japan eCTD submissions and support global eCTD submissions, ensuring compliance with submission-ready standards and regulatory requirements.
Requirements:
- Bachelor's degree
- Over 5 years in the pharmaceutical industry, focusing on regulatory operations like eCTD publishing and submission management.
- Experience in managing major submissions and assisting with project management.
- Fluent in Japanese and English.
- Proficient in Microsoft Suite, Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tools; experience with regulatory systems like Documentum, Veeva Vault, and docuBridge.
If you are interested, please apply with your CV attached.
