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Contributes to development of submission strategy for projects assigned
Responsible for building regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing portfolio.
• Contributes to development of submission strategy for projects assigned
• Provides input to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets assigned
• Establish within country, cross-product submission plan in association with Global/Regional Regulatory Lead, Regulatory CMC, commercial, affiliates &/or marketing partners
• Creates Content Plans to allow publishing & timely dossier submission.
• Responsible for building quality regulatory dossiers. Works with other functions as necessary
• Act as contact person in RA EMEA for local partners & affiliates as required
• Lead the organisation in the preparation of answers to questions from regulatory authorities.
• Responsible for ensuring that Celgene fulfils Regulatory Authority commitments.
• Ability to lead complex regulatory submissions for assigned projects
• Responsible for tracking all activities & for accurate submission plans in eQRMS and communicating any emerging issues to stake holders in a timely manner.
• Ensures that copies of regulatory documents are archived appropriately
• Can identify when to escalate issues to line management & knows when to seek advice.
• Proposes process improvements to manager. Shares best practice involving International regulatory submissions.
• Good understanding of high level strategic issues & implications of Company Core Data Sheet & Regulatory CMC.
• Bachelor’s degree in a scientific discipline or equivalent
• Experience of leading International Regulatory Affairs (RA) submissions
• Strong understanding of International regulatory landscape & required approaches/strategies.
• In-depth knowledge of regulatory requirements for countries assigned and good working knowledge of requirements across International region
• Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
• Understands constitution of CTD modules; non-clinical, CMC, Clinical
• Understanding of commercial goals and strategy for International region
• Takes initiative for professional development & seeks opportunities to learn from others
• Communicates complex ideas effectively across a culturally diverse environment & with Regulatory Authorities when tasks have been delegated
• Communicates effectively with Regulatory Authorities when tasks have been delegated
• Ability to influence internal stakeholders
• Effective project manager. Delivers quality projects in accordance with timelines. Prioritises tasks appropriately, coordinates the delivery of multiple projects
• Must be flexible & adaptable to changing project priorities & work assignments
• Displays a willingness to challenge the status quo & take calculated risks
• Understands contributions of other departments & external stakeholders
• Understands & utilises knowledge of local regulations & business practices when working across cultures
• Ability to travel
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