Genesis Pharma are currently recruiting for an experienced Regulatory Specialist/Manager to join an international Pharmaceutical company based in Baden-Württemberg.

 

Full time position with fantastic benefits available to all employees from day 1, flexible working hours and high competitive salaries. The really great part of this role is that in the coming year they will be expanding into multiple new European countries and will provide full training to their Regulatory team to give them exposure to these markets.

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Company is constantly growing and conducts major clinical development programs across the world. They offer competitive flexible packages and with immediate start dates but also willing to wait up to 3 months for the right candidate.

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Job Functions

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• You will perform central and local IRB/IEC and Competent Authority (CA) submissions on behalf of Sponsors and sites.

• Quality Check of Clinical Trial Application forms (CTA, XML).

• Receive and process study documentation from the sites, assessing accuracy and completeness. Interact with site personnel for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation. 

• Interact with Sponsors as needed, forwarding regulatory documentation to Sponsors according to Standard Operating Procedures (SOPs) or Sponsor Project-Specific Standard Operating Procedures (PSOPs). 

• Attend internal and external Study meetings and provide Regulatory status reports. Perform and compile all required documentations for submission to IRB/IEC (central and local) and to the CA. Prepare submissions to IRB/IEC and/or Cas. 

• Shipment of Annual Safety Compile site regulatory documentation for Investigator Site File according to SOPs or Sponsor PSOPs and perform a Quality Check review of documents. 

• Assist Project Managers with needed documents for submission in other EU Countries. 

• Assist Study Teams and Project Managers in all Regulatory requirements

• Check requirement for IRB/IEC submissions (central and local,)

• Track submissions to IRB/IEC and/or CA 

• Assist with training and mentoring of junior staff.

Requirements

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• Ideally Bachelor’s or Master Degree in Pharmacy or Natural Science 

• Around 5 years Regulatory Affairs Experience in Pharmaceutical company, Biotech or CRO

• Knowledge and understanding of international GCH / ICH regulations and guidelines in an EU country

• Knowledge of principles and correct standards in Clinical Research

Additional information

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• Permanent position available immediately

• Position based in Baden-Württemberg

• Package to define according to experience

• Flexible working hours available 

• Fluent level of English and Basic level of German is a bonus

• Interviews to take place immediately

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In order to apply for this role, please forward your most up to date CV and quote the reference number.

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TAGS: Regulatory Affaris