The company

At Otsuka Pharma Scandinavia AB (OPSAB), we are dedicated to making a difference in the lives of patients. OPSAB operates in the Nordics (Denmark, Finland, Norway, Sweden) and the BeNeLux (Belgium, Luxembourg and the Netherlands) where we market medicine within CNS, Nephrology and Hematology, striving to address high unmet patient needs. Our innovative pipeline fuels our commitment to providing groundbreaking treatments.

The Position

This is rare opportunity to join the QVRI Team within the Medical Affairs Department as the backup Local Safety Manger (bLSM) and Regulatory Affairs Manager (RAM). In this role you will work with both internal and external key stakeholders.

As a the bLSM and RAM, you will play an important role, being responsible for managing daily and proactive operations within pharmacovigilance (PV) and regulatory affairs at OPSAB. You will work with both internal and external stakeholders.

Your main responsibilities as bLSM include:

• Develop OPSAB PV processes in line with the company’s requirements
• Manage receipt and processing of safety information and product quality complaints including follow up activities and documentation
• Conduct the monthly reconciliations with internal and with external parties
• Prepare, organize and conduct local PV training
• Manage and/or conduct oversight of RMP-related PV activities including aRMM
• Maintain current knowledge of all local regulatory PV requirements in OPSAB countries
• Open and process PV related deviations and CAPAs to drive continuous improvement
• Ensure accurate filing, storage, and tracking of GxP records
• Support PV audits and inspections, ensuring audit/inspection readiness
• Act as the OPSAB LSM when required

Your main responsibilities, as RAM, include:

• Develop OPSAB Regulatory Affairs processes in line with the company’s requirements
• Responsible for the implementation of variations including SmPC and PL update
• Responsible for the review and approval of artwork (packaging components)
• Ensure update of national regulatory body product database within the OPSAB territory in collaboration with the Responsible Person for Good Distribution Practices
• Responsible for the coordination of the aRMM process for the territory as aRMM Lead
• Act as OPSAB Regulatory Affairs contact and user for relevant Otsuka electronic systems within the area
• Acts as the regulatory expert at OPSABs internal work and in dialogue with external partners.
• Monitor and implement new regulatory intelligence requirements and guidelines
• Support the QVRI Team in regulatory matters including audits, change controls, inspections, recalls and stock outs.

Who You Are

• Excellent knowledge of regulatory product databases
• Excellent communication and organizational skills.
• Excellent teamwork and cross-functional collaboration skills
• Strategic thinker

Qualifications and experience

• Education: University degree in a relevant field like science, biomedicine, pharmacist or nurse
• Experience: At least 5 years in regulatory affairs and/or product safety
• Knowledge: Strong knowledge of relevant regulations and guidelines
• Languages: Fluency in English; Fluency in one or more Nordic Language