Senior Manager in Regulatory Information Management (all genders) - part-time/full-time

Posted 04 Mar 2024

Darmstadt, Hessen - Germany

Req Id 272538

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your Role:

We are currently looking for a dedicated and enthusiastic individual interested in an exciting challenge in our regulatory affairs organization. As Senior Manager in Regulatory Information Management (RIM) you ensure efficient processes, manage and guide personnel and coordinate data management operations to ensure quality and timely delivery of high-quality regulatory data. You drive the regulatory transformation of the company to the next level considering innovative technologies like advanced analytics, process mining, automation and artificial intelligence. In contributing as an Expert with dedicated business process know-how for RIM you create standards for our multi-functional projects and central initiatives as well as the optimization of Veeva Vault RIM. You ensure data governance rules (master/metadata dictionaries, processes and data flow across multiple applications) are implemented and followed to achieve as well as maintain global data consistency of IDMP related applications and systems (RIMS, xEVMPD, IDMP). In addition to this you work on future oriented project and initiatives in correlation with the RIM vision and strategy regarding data management and system / process efficiency optimization. This leads to the fostering of a data driven mentality within Global Regulatory Affairs (GRA). You partner with GRA and other functions, departments and divisions and provide support, documentation, training and end user communication for regulatory data management related topics. In providing data management methodology know-how you support the processes in GRA Operations and in turn the user community to analyze system data and provide recommendations for these analyses. You support the data strategy implementation in RIM team while considering key data principles (e.g. FAIR).

 

Who you are:

  • Advanced university degree in a scientific field combined with sound background in regulatory, data management and an IT affinity.
  • 7+ years of experience from a pharmaceutical industry or service provider
  • At least 4 years in Regulatory Affairs with a natural curiosity towards data/information management
  • Good understanding of Regulatory Affairs business processes and experience in delivering improvements/changes to business processes
  • Excellent data management experience including data governance and master data management
  • Experience in Veeva Vault RIM
  • Practical knowledge of data management principles ALCOA+ and FAIR
  • In-depth expertise on both regulatory processes for submission of data and documents for medicinal products and utilization of regulatory systems (RIMS, DMS, SAP)
  • Proficient in English (written and oral)
  • Strategic, innovative and lateral thinking along with a pragmatic approach to work
  • Strong in conceptional work with the ability to implement practically
  • Strong customer orientation and good interpersonal skills
  • Work independently, Results-oriented, entrepreneurial and self-motivated
  • Agile mentality and change oriented


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


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