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Head of Regulatory Affairs & Quality Assurance
On behalf of our customer, Merz Therapeutics Nordics, we are looking for a Head of Regulatory Affairs and Quality Assurance to be part of an exciting building phase in the Nordics.
You will be joining a dynamic Nordic affiliate during an exciting period of growth, marked by the success of current sales and the anticipation of two new products. In this role, you will play a critical part in driving the continued expansion of the company across the Nordic region, contributing to its broader global scale-up efforts.
KEY RESULT AREAS & MAIN DUTIES
Regulatory Affairs
-Planning and managing regulatory submissions for new or already marketed product registrations.
-Ensuring portfolio maintenance in compliance with national, MRP, DCP and CP procedures.
-Providing regulatory support to internal and external customers (health authorities, partners, medical team, etc.) and assisting tender management and reimbursement process.
-Reviewing national documents, labelling texts and artwork.
-Acting as the main point of contact for regulatory issues.
Quality
-Planning, execution, and reporting of self-inspections for Merz Therapeutics Nordics.
-Planning, execution and reporting of vendor audits, internal audits and branch audits e.g., medical information staff, pharmacovigilance, distribution warehouses, pest control for warehouses if relevant.
-Preparation, support, and follow-up of authority audits (GVP inspections and Notified Body).
-Development, maintenance, and control of Merz Therapeutics Nordics AB QA Systems - interface to Global Quality.
-Creation of Merz Therapeutic Nordics SOPs in the system Smart Solve - Key User for Smart Solve.
-Creation of training plans and coordination for SOPs as well as applicable legislation and guidelines.
-Regulatory Intelligence part of the tasks - assess the local legislation or its changes regarding the impact on the local and global business and to identify resulting tasks for the affiliate, if necessary, in cooperation with other experts from the affiliate.
-Recording and assessment of product related technical complaints in collaboration with -Customer Service Managers.
-Archiving of regulatory controlled documents.
-Participation in the Local Emergency Management Team- implementation of tasks.
-Documentation and reporting of non-conformances (creation and follow-up of CAPAs also from audits).
-Hosting of local inspections and audits of Headquarters.
-Creation and reporting of KPIs to management (creation of bi-annual quality management report).
-Collaboration in the preparation of Quality Agreements and Outsourcing Contracts.
PV & Safety
-Setting-up and maintenance of a local state-of-the-art pharmacovigilance (PV) system.
-Interface between the EU-QPPV / Global PV and the local regulatory authority.
-Act as primary contact for PV for the local Competent Authority in the Territory.
-Issue and maintenance of written PV procedures (i.e. Standard Operating Procedures, -Working Practices) related to the local PV tasks and obligations.
-Local ICSR and product quality complaint collection, tracking, translation and exchange with the global departments in close collaboration with Customer Service Partners.
-Local adaptation and implementation of Periodic Safety Update Reports, Risk Management -Plans and Educational Material.
-Implementation of additional Risk Minimization Measures (e.g. product or batch Recall, Urgent Safety Restrictions, Dear Doctor Letters, etc.) in collaboration with the global departments, as applicable.
-Local signal detection activities.
-Set-up and Maintenance of first level Medical Information/Affairs function.
-Alignment and Collaboration with Medical Manager and MSL functions.
-Participation in PV-relevant audits and inspections together with the global functions and the EU-QPPV.
-Ensure PV training of affiliate employees, service providers and third parties.
You will be part of the management team and report to the General Manager, Nordics.
COMPETENCE REQUIREMENTS
-Bachelor’s degree in Life Sciences or Pharmacy.
-At least 4-6 years of experience working in Drug Regulatory Affairs.
-Knowledge of regulatory procedures and legislation for drug development, product registration, line extensions and license maintenance.
-Solid knowledge of the Nordic and EU legal regulations related to registrations of medical products.
-Familiarity with labelling and artwork management in the Nordics.
-Preparedness to travel locally and internationally.
WHO ARE YOU
-Advanced interpersonal skills, excellent in building relationships.
-Personal confidence to interact across a wide range of cultures and levels.
-Strong work ethic with high levels of resilience.
-Confident, quick thinking, responsive and solution oriented.
-Strong ethical compass with ability to good judgement when acting alone.
-Great communication skills in minimum one of the Nordic languages and English.
-Project management skills.
-Good organizational skills and ability to work independently.
-Analytical skills, to understand and simplify complex regulatory, quality and PV opportunities and challenges.
Interested? Please contact us at Brice Group;
Anders Larsson +46 73 203 46 91, anders.larsson@brice.se
Adina Lekberg Salamon +46 73 974 43 34, adina.lekbergsalamon@brice.se