- Regulatory support and oversight of development projects with a focus on Europe
- Review of regulatory submissions and assessment of regulatory requirements
- Collaboration on joint development and consultation on scientific issues from a regulatory perspective
- Preparation of regulatory submissions with a focus on quality documentation (CMC)
- Regulatory management (submission and support) of national and international EU regulatory procedures for medicinal products and other countries, including new submissions, change notifications, deficiency letters, and change control
- Responding to regulatory inquiries from our partners and regulatory authorities in Germany and abroad
Regulatory Affairs Manager (all genders)
Ingelheim
Full-time
Permanent employee
Your mission
Your profile
- A degree in the natural sciences (preferably pharmacy or chemistry) with at least 4 years of professional experience in regulatory affairs
- Extensive knowledge of CMC (finished products and, where applicable, active pharmaceutical ingredients)
- Good knowledge of quality requirements for active pharmaceutical ingredients and the development of finished pharmaceutical products, as well as a solid understanding of medical principles
- Strong knowledge of national and international regulatory requirements for the approval and maintenance of medicinal products (EU-EMA, WHO guidelines, ICH guidelines, etc.)
- Excellent written and spoken English and German
- Enjoyment of interdisciplinary teamwork, as well as a high level of commitment, initiative, creativity, and enthusiasm
- Willingness to travel occasionally
Our Offer
- A job in an established and renowned family business that offers you the security of over 35 years in business as well as a personal and appreciative working atmosphere
- Flexible working hours and 30 days' vacation
- Comprehensive training opportunities with a fixed annual training budget
- A modern working environment
- Various benefits such as JobRad, EGYM Wellpass, employee restaurant, regular events and much more.
- We have flat hierarchies and small teams - this enables us to have clear and direct communication channels that lead to fast decision-making processes
- We are looking for you as a personality and want you to make an authentic contribution - we encourage this in turn by giving you plenty of scope for creativity and independence
About us
Where people make the difference
Everyday work at Midas Pharma is diverse and challenging. This is what motivates and inspires us. That is also reflected in the people who work here: Our employees make the difference.
We know: We accomplish more as a team. This is the only way to transfer knowledge and create the synergies that make us so successful as a company. That's why teamwork is a key factor for us. For our employees, this means that there is scope to make a difference and take on responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making processes and highly competent team members. An inspiring environment that motivates you to go the extra mile. In the work for our customers and in the development of your own skills.
Everyday work at Midas Pharma is diverse and challenging. This is what motivates and inspires us. That is also reflected in the people who work here: Our employees make the difference.
We know: We accomplish more as a team. This is the only way to transfer knowledge and create the synergies that make us so successful as a company. That's why teamwork is a key factor for us. For our employees, this means that there is scope to make a difference and take on responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making processes and highly competent team members. An inspiring environment that motivates you to go the extra mile. In the work for our customers and in the development of your own skills.