Regulatory Affairs Manager (m/f/d)

Ingelheim, Germany:
The Regulatory Affairs Division of Midas Pharma GmbH is looking for a Regulatory Affairs Manager (m/f/d) at the earliest possible date

Arbeitsplatz

Your function covers:

  • Regulatory assessment of expected EU-regulatory-demands for the approval of non-generic drugs 
  • Active partin the regulatory support of development projects
  • Participation in the joint development of new strategies and advice on scientific issues from a regulatory perspective
  • Preparation of EU approval documentation in cooperation with other departments
  • Application and monitoring of European marketing authorisation procedures for drugs and international projects
  • Responding to inquiries from our national and international partners and the authorities
  • Requirements and Qualifications
    • You have successfully completed your studies in natural sciences (preferably pharmacy or chemistry) and have at least 3 years of professional experience, primarily in the field of non-generic products (APIs and/or FDFs)
    • Good knowledge of the regulatory requirements for non-generic drugs in the EU
    • Good knowledge of the national and international regulatory requirements for the new marketing authorisation and maintenance of drugs (EU drug laws and guidelines, WHO guidelines, ICH guidelines, etc.)
    • Very good English and German skills, written and spoken
    • Secure handling of MS Office, eCTD Software
    • You enjoy working in interdisciplinary teams
    • You are willing to travel on business from time to time
  • Our offer
    • An interesting and challenging task in an internationally oriented pharmaceutical company
    • A friendly and cooperative working atmosphere within our team
    • We are embracing the culture of a mid-sized company and therefore highly value a personal and respectful interaction
    • Flat hierarchies and short decision paths
  • Remuneration & Benefits

    In addition to an attractive salary, Midas offers a wide range of additional benefits as significant added value for our employees.

    Learn more about our benefits

Have we caught your interest?

We are looking forward for your application (please send a PDF and mention your availability and salary requirements) to:

Your Contact

Stefan Schröder

Stefan Schröder

Human Resources & Administration
Director

Midas Pharma GmbH
Rheinstraße 49
55218 Ingelheim
Germany
  • 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

    Employee data

    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.

    Applicant data

    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

    1. Applicant data
      Personal data of applicant are saved by Midas only until the decision of the recruitment of the applicant.
    2. Rejected applicants
      Personal data of applicant are saved for a period of five months after informing the applicant about his rejection.
    3. 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.

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