Regulatory Affairs and Medical Compliance Assistant (MWD)

General Job Responsibilities:

Conducts activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Completes all required training on the AZ Code of Conduct and supporting Policies and Standards on time reports any potential issues of non-compliance.

Main tasks:

• Acts as a super user for the Regulatory Sharepoints (maintenance and further development).
• Prepares the Fachinformation Gebrauchsinformation and Fachkurzinformation out of the approved text for the cross functional teams
• Handles and documents information on parallel imported products.
• Assists the RA team with generic administrative tasks incl. Purchase Orders and vendor management meeting organisation travel and training etc.
• Supports the regulatory team in all activities related to budget monitoring and control.
• Supports the Regulatory team in all the activities related to the registration and maintenance of products as well in GRP (Good Regulatory Practice) in compliance with all local and global codes standards and procedures.
• Supports the maintenance/revision and creation of RA SOPs and the Business Continuity Plan (BCP). Organize the yearly testing of the BCP.
• Oversees organises and manages the Regulatory Affairs digital and hardcopy archive ensuring appropriate archiving according to the retention guideline (acts as the RA team Archive Coordinator).
• Supports the RA team and the Medical Team/Medical Director in the quality assurance and business compliance area (e.g. due diligence processes).
• Cooperation and mutually backing up with the Medical Affairs Assistant for essential tasks during planned and unplanned absences and workload by regularly align and exchange to ensure a consistent way of working.
• Supports Compliance Business Partner with the Quarterly Compliance Monitoring activities for the MC.

Education:

• Matura/ Abitur
• International baccalaureate or equivalent education

Working Knowledge/Experience:

• At least 3 years proven professional experience in industry preferably in the pharmaceutical sector or in the healthcare sector
• Command in English and German (written and spoken)

Functional skills/ competencies

• Agile thinking paired with pragmatic approach
• Efficient meticulous and self-motivated way of working
• Project and process management experience
• Strong organisational skills with oversight and ability to manage complexity under set timelines
• Strong willingness to learn

Soft skills & Technical competencies

• Proficient MS Office
• Ability to work with new technologies
• Brings innovative and creative ideas within a regulated setting
• Strong interpersonal and team interaction skills

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.