Regulatory Affairs Manager – Europe Team- Immunology

3 weeks ago

Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time
Job Description

Job Summary

Is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. Supports clinical trials strategy as required.

Highlighted

responsibilities:

Products
Responsible for appropriate Europe Region regulatory input to project teams and Global Regulatory Slides via the Global Liaison and Global Regulatory Teams.Responsible for ensuring planned drug development activities comply with Europe Region guidelines and in cases where they do not provides a critical analysis of the risks and issues.Makes recommendations to Global Regulatory and drug development teams in order to shape the global strategy in line with regional/commercial objectivesSupports the drug development strategy; defining options for Scientific Advice/Peadiatric Investigation Plan, creating briefing packages and co-ordinating and leading agency meetings.Defines Europe region filing strategy (including CP, MRP, DCP); identifying risks and issues.Responsible for ensuring effective implementation of filing plan, publishing and archiving of documents.Responsible for ensuring effective planning, tracking, archiving of activities, especially submissionsn and key correspondence. Ensures effective planning and tracking of activities via internal toolsSupports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.
People
Establishes strong and effective relationships with "in country" and global regulatory teams thereby ensuring RA activities are in line with regional business priorities.
Processes
Follows Global Regulatory policies and procedures. Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency, ensures that new processes are aligned with global policies, but also meet regional regulations and needs.

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