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Senior Manager Regulatory Submissions Process Development
hace 1 mes
The Senior Manager Regulatory Submissions Process Development will lead a worldwide delivery team within IQVIA Translations. This team is responsible for developing and harmonizing the Regulatory Submissions Process. The ideal candidate will have experience working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for EMA, SwissMedic, FDA, and the rest of the world.
Key Responsibilities
• Lead Regulatory submission Team Leaders under their remit and ensure the whole team meets and exceeds their monthly and yearly goals and objectives.
• Implement processes to improve efficiency and ensure high-quality deliverables for all Regulatory Submissions projects.
• Coordinate with colleagues in other departments to develop and expand on existing workflows and offerings.
• Represent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projects.
• Act as the main point of contact for internal/external clients and manage any escalations or issues that may arise within the team.
• Liaise with the client to establish methodologies and assess and agree project parameters and requirements.
• Prepare and implement smooth on-boarding plans for future new clients.
• Collaborate with Vendor Managers to develop an extensive network of Regulatory Submissions linguists and subject matter experts.
• Monitor and manage the status of the teams' projects to effectively anticipate and prevent issues.
• Ensure that the team accurately and timely completes project finances, including quoting and budgeting.
• Understand and adhere to the Quality Management System.
• Comply with relevant and applicable IQVIA procedures and SOPs.
• Maintain and update SOPs when applicable.
• Work with Team Leads to help in the training and development of junior staff.
• Collaborate closely with the Quality and Compliance team to ensure best standards are reached.
