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  • Regulatory Affairs Manager (all genders) Ingelheim am Rhein
  • Midas Pharma in Ingelheim am Rhein, , Germany
  • jobs
  • 2 weeks ago

jobs description

Your mission
• 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

Your profile
• 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 a personal and appreciative working atmosphere in addition to the security of over 30 years of business
• Our workplaces are not open-plan offices, but personal offices where you can also retreat from time to time, equipped with the latest technology and ergonomic office furniture
• Our organization enables you to make quick decisions - a key factor of our success
• Due to our flat hierarchies, there is a very close interaction at Midas - personal and professional - it is not uncommon for management 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 great freedom for creativity and independence
• At Midas, all paths to personal and professional development are open to you - various support programs as well as assignments abroad are just a few possibilities

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
Ingelheim am Rhein Germany

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