Regulatory Affairs Manager (m/f/d)

Where people make the difference

The working day at Midas Pharma is varied and challenging. This challenge motivates and inspires us. This is also reflected in the people who work here: our employees make the difference.

We know: In the team we reach more. This is how knowledge transfer works, only so we create the synergies that make us so successful as a company. This is why teamwork is self-evident. For our employees, this means: here there are spaces to move and take responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making and highly-competent colleagues. An inspiring environment that motivates you to go one step further. Working for our customers and developing their own skills.

Regulatory support and responsibility of development projects with a focus on Europe Assessment of regulatory documents and regulatory assessment of regulatory requirements Participation in joint development and advice on scientific issues from a regulatory perspective Creation of certification documentation focusing on quality documentation (CMC) Regulatory Management (application and accompaniment) of national and international EU authorisation procedures for medicinal products and other countries incl. New submissions, change indications, deficiencies, change control Answering regulatory requests from our partners and authorities in Germany and abroad

Complete study of natural sciences (preferably pharmacy or chemistry) with at least 4 years of professional experience in Regulatory Affairs Extensive knowledge in the field of CMC (products and, if appropriate, active ingredients) Good knowledge of the quality requirements for active ingredients and the development of finished medicinal products and a medical understanding Good knowledge of national and international regulatory requirements for re-accreditation and maintenance of medicinal products (EU-EMA, WHO guidelines, ICH guidelines, etc.) Very good knowledge of English and German in word and writing fun in interdisciplinary work in the team as well as high commitment, initiative, creativity and enthusiasm readiness for occasional travel

A workplace in an established and renowned family business that offers you a personal and value-adding working environment in addition to the safety of over 35 business years Gliding working hours and 30 days holiday Comprehensive training opportunities with fixed annual training budget A modern working environment Various benefits such as JobRad, EGYM Wellpass, staff restaurant, regular events etc. We have flat hierarchies and small teams - this allows us clear and direct communication channels that lead to quick decision-making processes We are looking for you as a personality and want you to be authentic – we are promoting this through great freedoms for creativity and self-sufficiency