Regulatory Affairs Manager (m/f/d) CMC (API)
The Regulatory Affairs Managemant of Midas Pharma GmbH is looking for a Regulatory Affairs Manager (m/f/d) CMC (API) at the earliest possible date
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 and Qualifications
- 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)
- 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
Remuneration & Benefits
In addition to an attractive salary, Midas offers a wide range of additional benefits as significant added value for our employees.
Have we caught your interest?
We are looking forward for your application (please send a PDF and mention your availability and salary requirements) to:
Human Resources & Administration
Background information on Midas Pharma
Midas Pharma founded in 1988 and headquartered in Germany, is an internationally operating pharmaceutical company, offering pharmaceutical services in Licensing, Intellectual Property Management, Regulatory Affairs and Auditing. Furthermore Midas is active in sourcing, supplying and developing finished products, active ingredients and intermediates. Midas Pharma is internationally presented by affiliated companies in France, Italy, Denmark, Poland, USA, China, India and Japan and currently employs approximately 200 associates worldwide.
In our international setting we offer you a strong team spirit based on partnership, the dynamics of rapid growth as well as the security of an established, successful company.
Further information about the company
Applicant Data Protection
Midas raises, uses and processes employee data, which are used for the purpose of establishing, maintaining and terminating of working relationships. Thus, all data that are necessary for the future course of the working relationship, are being collected by Midas.
The purpose of an job interview is it to get to know the applicant. During such job interviews all kind of personal data are brought to the attention of Midas. These data are raised, used and processed by Midas. The personal data comprise of the particulars of the applicant such as but not limited to the kind of data which came up during a job interview are e.g. name, contact data, age, job, languages, certificates, soft skills and also parts of the c.v. (personal interests, hobbies…). A photo is also a part of personal data concerning the applicant.
a.) raising, using and processing of the applicant data
Midas only collects data, which are necessary for the establishment of the employment of the applicant.
b.) saving time of data
- Applicant data
Personal data of applicant are saved by Midas only until the decision of the recruitment of the applicant.
- Rejected applicants
Personal data of applicant are saved for a period of five months after informing the applicant about his rejection.
- Adjusted applicants
After a successful recruitment, the job applicant data are saved for the term of the employment. Thus, the applicant data are going to be part of the personnel file in order to check his suitability concerning new requirements.
c.) deletion of the applicant data
After five months, the data of rejected applicants are going to be deleted. This applies to all electronically saved personal data of the applicant. The application documents in paper will be sent back to the applicant, but only if the application was not an unsolicited application. Within this time, only human ressources devision has access to these data.
d.) talent pool of rejected applicants
Rejected applications could be interesting for Midas in future. Thus, it is interesting for Midas to save some of the applicant personal data. For this reason, if you expressly agree, probably your applicant data are saved by Midas. The statement of consent will be sent to you, if your application is rejected. Only if you return the signed statement of consent. your data are going to be saved.
e.) Data transmission to third parties
Your personal data are going to be transmitted to third parties, but only if you expressly agree or there is a legal authorization. The transmission is only performed, if your protectionable interests are ensured. Midas ensures, that a appropriate protection level is granted.
- Applicant data