Manager - Regulatory Operations & Publishing
On-siteAll, Catalunya, Kingdom of Spain
Job Summary
Lead global regulatory operations teams managing submission strategy, publishing (eCTD/Non-eCTD), and lifecycle activities for assigned generic products. Oversee end-to-end vendor management, data archival, and security while ensuring adherence to ICH standards and regional health authority portals. Drive digital transformation through Amplexor RIMS optimization, automation, and data standardization initiatives to improve operational efficiency. Forecast activities, manage hiring, and mentor a high-performing global team of regulatory professionals. Represent Regulatory Operations in leadership forums, audits, and GRA governance meetings to support product development and market supply worldwide.
Required Qualifications
- At least Master's degree
- Minimum of 15+ years of hands-on experience within Regulatory Operations & Submission management industry experience for Innovative portfolio
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner
- Strong listening skills
- Aware of the regulatory activities for NDAs, CFT
- Management capability of leading a group of team members
- Proficient in English, spoken and written
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
- Demonstrated effective leadership, communication, interpersonal and negotiating skills
Desired Qualifications
- Additional qualification in regulatory data management
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