Regulatory Operations Specialist

To support Global Regulatory Affairs Managers and Scientific Experts on an operational basis, the Regulatory Operation team is coordinating and archiving regulatory data (e.g. GLP study reports, GLP raw data), is maintaining different regulatory IT working platforms & systems (e.g. for dossier preparations) and provides support like the mandatory notification of new studies to authorities, preparation and shipment of regulatory documents to authorities as well as to customers.

Job ID: 29992

The Regulatory Operations Specialist is a team member of the Regulatory Operation team working on these operational duties and with that to provide a high-quality support for an international Regulatory team working at different company sites (e.g. Cologne, Leeds, Paris, Tel-Aviv).

Responsibilities:

• Archiving of GLP study reports acc. to specific quality criteria in the regulatory data base.
• Mandatory notification of new studies to European authorities.
• Global management of GLP raw data from regulatory studies stored in contract labs as well as central GLP archives in different countries.
• Maintaining and supporting of different Regulatory-specific working platforms & systems for dossier preparation and knowledge sharing inclusive management of access rights for internal as well as external contributors.
• Management of the preparation and shipment of specific regulatory documents to authorities as well as to customers within short deadlines.
• Close interaction with colleagues working in a dynamic international environment to provide high quality support to Global Regulatory & Scientific Affairs team.

Qualifications & Skills:

• At least 3 years of proven experience in a similar operational role.
• Proficient computer skills is a must with good knowledge of relevant software such as MS applications (Sharepoint, Word, Excel) and experiences with data base applications.
• Experiences with the data base / IT system IUCLID would be an advantage.
• Supportive and service-oriented attitude with a structured and efficient way of working.
• Proactive mind-set with a pragmatic and reliable can-do attitude.
• Cross-functional working capabilities with good interpersonal skills as well as intercultural skills.
• Professional and responsive communication skills fluently in English and German (both orally and in writing).
• Bachelor degree an advantage

Location:

• Adama office in Cologne, Germany.
• We are working in a hybrid model with three days office presence and the option to work two days from home office.