Responsibilities :

• Supporting to elaborate, establish and apply the RA standard at all sites.
• Helping to ensure the internal standard in the regulatory compliance maintenance of the regulated products under consideration of customer requirements.
• Consult the local RAC teams in developing the CMC and regulatory strategy for new development projects with customers and internal and external development groups as required and requested by the customer and assure that the corporate RAC standard is applied.
• Guiding operators through the issuance, submission, and maintenance of all regulatory documents (DMF’s, CMC documentations for INDs, IMPDs, NDAs, MAAs, etc.).
• Providing hands-on support in the implementation and application of the corporate standard at the respective sites.
• Coordinating the regulatory activities of all CARBOGEN AMCIS RAC groups during the CMC process development for corporate projects and consulting the CARBOGEN AMCIS and customer project teams in regulatory questions and as requested and agreed with the customer.
• Chair the corporate RAC organization as part of the Corporate Quality Organization.
• Taking over process ownership of the RAC chapter in the Corporate Management Handbook, define and maintain a harmonized RAC standard.
• Maintaining the e-CTD submission software

Requirements :

Your benefits :

For further information please contact the Human Resources department.