Regulatory Affairs Senior Manager

<p>Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!</p><p></p><p></p><h1><b>Job Details </b></h1><p></p><p></p><p><span>Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.</span><span> </span></p><p></p><p><b>Responsibilities:</b></p><ul><li><p>Develop and maintain strong client relationships and help drive opportunities for increased service support to Line Manager.</p></li><li><p>Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.</p></li><li><p>Preparation, review and compilation of documents within the framework of regulatory affairs projects.</p></li><li><p>Communication with clients and Health Authorities.</p></li><li><p>Support with scientific advice procedures and representation of clients with health authorities.</p></li><li><p>Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners.</p></li><li><p>General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.</p></li><li><p>Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.</p></li><li><p>Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise.</p></li><li><p>Ensure personal leadership in supporting VDC strategy implementation and optimization.</p></li><li><p>Comply with, maintain and contribute to optimizing internal processes.</p></li><li><p>Provide day to day operational support for colleagues.</p></li><li><p>Support with VDC led commercial, marketing and business development activities including proposal input.</p></li><li><p>Oversee project team to ensure delivery to budget and manage resolution of any invoicing queries.</p></li><li><p>In agreement with Head of VDC REG providing on-site regulatory support to GCS clients.</p></li><li><p>The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG.</p></li><li><p>Leadership and coaching of the direct reports; conduct of probation period, annual employee evaluation, personal development and goal setting meetings where applicable.</p></li><li><p>Maintain oversight of direct reports utilization, capacities and capabilities and communicate to Team Lead. Escalation of issues to LM/HR accordingly.</p></li></ul><p></p><p>.</p><p><b>Experience:</b></p><ul><li><p>University degree in Life Science.</p></li><li><p>Proven in-depth professional experience in area of responsibility; extensive knowledge of discipline or department, solves complex problems, strong understanding of the business.</p></li></ul><p></p><p><b>Skills:</b></p><ul><li><p>Ability to translate strategical goals of <span>partnerships/customer</span> or internal projects into tactical goals and implement concrete milestones; ability to define appropriate escalation process.</p></li><li><p>Structured, analytical, systematic and independent way of working; wide discretion to take action consistent with operating policies; determine priorities.</p></li><li><p>Lead extensive project reengineering activities and provide consultation related to change management. Proactively identify up/cross selling opportunities. Ensure that the team identifies, documents, and drives resolution for program issues.</p></li><li><p>Demonstrable ability in leading, mentoring, managing and motivation of staff.</p></li><li><p>Ability to lead project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according project milestones.</p></li><li><p>Ability to manage internal and external (client) relationships on level of client's department heads; ability to discuss and align mid-term goals of collaboration.</p></li><li><p>Very good communication skills (written and verba