Global Delivery Senior Manager
An exciting opportunity has arisen for a Senior Global Delivery Manager at a multinational biotechnology company in Berkshire. The bright individual will be able to step up and grow organically within the company which is perfect for an individual who is looking for a career development.
- Responsible for global electronic submissions and documents meeting regulatory agency and internal submission standards and technical requirements.
- Demonstrates expert knowledge of submission or technology-related Global Health authority guidelines/regulations.
- Oversees publishing deliverables and vendor activities on a day to day basis to ensure successful execution of operational activities for assigned products.
- Internal influencing, socializing and communication of changes.
- Responsible for understanding and communicating impact of Industry / Agency changes relevant to submission sciences, in partnership with vendor and driving innovative process change for improved efficiency.
- Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets.
- Maintain current regulatory knowledge and keep abreast of regulatory procedures and changes related to the electronic Common Technical Document.
- Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH/global eSubmission regulations.
- Acts as a liaison between members of submissions and other functional areas in order to ensure timely submission of regulatory-compliant, quality documents.
Skills and Requirements
- 6 to 8+ years pharmaceutical and regulatory experience (biotech products preferred)
- 4 to 6+ years regulatory operations experience
- SME in eCTD
- SME in regulatory operations processes
- Strong communication and project management abilities in global and virtual teams
- Competent in the use of electronic document management and submissions publishing tools.
- Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected
- Bachelor's Degree (life sciences preferable, IT/Business acceptable)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.