Cache of job #14088274

Job Title

Regulatory Affairs Submissions Team Lead

Employer

CPL

Location

DUBLIN WEST

Description

On behalf of our client, a global pharmaceutical company, are currently recruiting for a Regulatory Affairs Submissions Team Lead. Objective: In conjunction with the Regulatory Submissions Manager you will assist in the departmental processes for APTL products and brands. This role will require a proven track record in submissions and Team Supervision. Duties: Lead and assist a team of Regulatory Affairs Officers. Coordination & preparation of regulatory submissions assigned to the Submissions team. Ensure that the documentation prepared by Regulatory Affairs Officers is complete and complies with applicable regulatory requirements. Negotiate and communicate effectively with other functions and regional offices to obtain timely product approvals. Ensure that timely responses to the regulatory queries raised during the evaluation process are provided by the team to the regional offices. Close cooperation with other team leaders in order to support all Submission processes and disseminate knowledge through the whole RA department. Ensure all activities are within the framework of the Quality system, including the setting and achievement of relevant KPIs. Evaluates the tracking flow of projects against established time lines and prioritises activities based on changing requirements. In conjunction with the Submissions Manager, contribute to the completion of all technical and operational activities for artworks projects through management of internal and external resources. Train new employees in SOPs and documentation systems. Evaluate the tracking flow of projects through the artwork development process against established time lines and prioritise activities based on changing requirements. Maintains and enhances cross-functional team relationships. Lead a team that consists of several Regulatory Affairs Officers and support the manager with: 1. Assigning, coordinating and reviewing of performance for day-to-day tasks allocated to the led team, 2. Determines priorities, timetables and assigns resources and tasks and is accountable for results, 3. Preparation of the regular reports regarding the assigned tasks/procedures progress, 4. Monitor operations to ensure compliance with regulatory requirements, 5. Assessing the team training needs and preparing the training programmes while minimising cost and downtime, Provide the cross-functions team with Regulatory input in order to obtain timely regulatory approvals for the products as part of the product development/registration strategy planning. Implement QA systems and generate SOPs. Requirements. Bachelors or Post Graduate degree in science. Effective use of appropriate IT systems and programs. Ability to communicate information effectively and clearly in written form and orally, and at levels appropriate to the needs of different internal and external customers. People Management Experience. For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671.

Date Added

1569 days ago

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