Associate Director Regulatory Affairs

1. Management responsibility
Strategic alignment
• To organize regular work-meetings with various disciplines in business and R&D departments, to ensure the required stream of information, and adequate strategic planning for budget, MTP and long term projects (global project planning).
• To organize regular work-meetings with various disciplines to ensure the required stream of information is incorporated
• To ensure operational alignment of RA activities with other functional departments
• To ensure adequate planning and resources to adhere to the targets defined in the Business (Review) Meetings 

Co-ordination and reporting
• To ensure that RAM’s are supplying the regulatory planning for their region and products on a regular basis to generate an affiliate planning and objectives
• To challenge the RAM planning on an individual basis, to optimize the planning for the company
• To secure approval of the (proposed) strategic objectives and planning by the Medical Director. Both short (1 yr) and mid term
• To monitor the implementation and follow-up of the agreed activities, and where required take action for correction or improvement
• Responsible for achieving the objectives as agreed in the planning
• To secure an accurate and pro-active monthly reporting to the Medical Director
• To secure updating of all relevant databases
• Responsible for timely reporting to the Medical Director, if projects and timing might be or are jeopardized, and propose corrective action

Quality management
• Responsible to make proposals to the Medical Director, related to development of procedures, SOPs, quality management tools, and databases
• Continuous monitoring of activities and output of the RA group and making proposals to improve
• Continuous updating of the Regulatory Intelligence database

Team management
Functional, operational and hierarchical management of regulatory team
• Lead, develop and manage the regulatory managers
• Ensure appropriate coaching and training
• Appraise staff and make development plans

2. RAM responsibility
• Prepare a MAA file (or other type of regulatory submissions)
• Participate in regular cross Sectional meetings in Regulatory Affairs to discuss and confirm planning of regulatory submissions (both new submissions and maintenance related submissions)
• Participate in regular meetings with management of the relevant region(s) of the International Department / Affiliate to discuss and confirm planning and priorities of regulatory submissions
• Assess registration activities for relevant products in relevant region for coming MTP period by preparing a Regulatory International Plan

Management responsibility
• Over 40 countries
• To secure new submissions and maintenance of existing MAAs of bulk and half products, as agreed upon in license agreements
• Broad regional responsibility, for Europe, Near & Middle East, Africa, Australia
• In total management of several hundreds of registrations