Regulatory Affairs Manager (m/f/d) CMC (API)

 Jobomas DE
 Deutschland, Ingelheim am Rhein, Rhineland-Palatinate
 vor 4 Tage, 3 Stunden
Join Midas Pharma and become part of a corporate culture where you can contribute and develop personally and thereby make a real contribution. Experience the Midas Spirit, which motivates us all to achieve our best every day, and a working environment full of appreciation and creative freedom, where you and your ideas count. Midas Pharma - Where people make the difference! Your function covers Regulatory advice and responsibility in relation to development and transfer projects with a focus on chemically defined active ingredients Evaluation of regulatory documents, including due diligence Conception, discussion and support in the implementation of regulatory strategies of projects (set-up, realization and lifecycle) Accompanying project management with focus on regulatory support (participation in external and internal meetings/teleconferences/visits) Preparation of regulatory documentation for active pharmaceutical ingredients with focus on quality documentation (CMC) Submission and support of national and international registration procedures for APIs (EU, USA, Brazil, China and other markets), especially for the Midas Own-API pipeline, incl. change notifications, deficiency letters, change control Maintenance, servicing, synchronization of national and international approvals in accordance with legislation, applicable guidelines and Midas strategy. If required (e.g. new markets, customers or directives) re-evaluate and align regulatory strategy and implement with relevant departments Direct exchange with partners and authorities in Germany and abroad on regulatory relevant issues Requirements & Qualification Degree in chemistry, preferably with a PhD, with a focus on analytical or organic chemistry preferred Ideally knowledge or interest in development, cross-verification, transfer and/or validation of common analytical methods (regulatory as well as technical) At least 5 years of professional experience in the field of CMC (active pharmaceutical ingredients) Good knowledge of quality requirements for active pharmaceutical ingredients Good knowledge of specific national & international regulatory requirements for new drug registration and maintenance of active ingredients (EU/US-FDA drug laws & guidelines, WHO guidelines, ICH guidelines) Very good knowledge of German and English, both written and spoken Confident handling of MS Office as well as strong communication skills and team spirit Willingness to work in an interdisciplinary manner High level of commitment, initiative, strategic thinking, flexibility, creativity and enthusiasm Willingness to travel occasionally (project-related) Our offer Midas Pharma is a well-established and renowned family business that offers you an attractive salary, a nice working atmosphere in addition to the reliability of more than 30 years of business experience Our organization enables you to make quick decisions - a key factor of our success Due to our flat hierarchies, there is a very close collaboration at Midas - personal and professional - it is frequent to be involved in interdisciplinary projects We are looking for you as a personality and want you to contribute authentically - in turn, we encourage this by giving you freedom for creativity and independence At Midas, all paths to personal and professional development are open to you – as you develop in your career, Midas Pharma is offering various support programs as well as assignments abroad are just a few possibilities Have we caught your interest? We are looking forward for your application (please send a PDF) to: Midas Pharma GmbH Human Resources

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