Job Description

Manager Regulatory Affairs Pharma Lead the joint efforts for the development of the global API product approval strategy for food and pharma products in a timely and accurate manner. Manage and support the food and pharma submissions (i.e. new registrations, renewals of authorizations or line extensions) in certain regions or countries Coordinate the submission of dossiers to the regional authorities and follow up on the approval process. Monitor and report modification of the changing regulatory framework and environment, and assess their impact on the business Develop SOPs, work on and/or select appropriate regulatory platforms & applications (software solutions), as appropriate to specific issues. Contribute to the development and maintenance of registration status & planning platforms. Highly contribute to the RA team performance by taking leadership in development and maintenance of efficient RA tools, processes and coaching of employees and junior colleagues, as applicable Support Total Quality Management for the product-specific aspects (e.g. specifications) in customer quality agreements, as needed. Support issue management related to product quality, e.g. impurity complaints, in close cooperation with all internal functions (e.g, QA, Marketing & Sales, Product Management) and represent Regulatory Affairs. Responsible for global or regional representation, networking and shaping activities, where applicable. Support for global standard product document creation, update and maintenance. The activities linked to the position are highly complex due to the dynamics of the global market and changing regulatory environments. Your responsibility will encompass the integration of the Marketing and Sales plans into your regulatory strategy program and its global roll out in cooperation with the regional teams. You will be part of a highly professional and motivated team. Experienced / skilled in use of related regulatory IT platforms & applications such as Veeva RIMS, Documentum, Trackwise Ability to assess, manage and communicate regulatory risks for given submissions or situations