Head of Regulatory Affairs and Quality Assurance

2 months ago

Stockholm, Stockholm, Sweden Merz Therapeutics - Europe Full time
Job Description

**About the Role**

We are seeking an exceptional individual to join our team as the Head of Regulatory Affairs and Quality Assurance at Merz Therapeutics - Europe. In this pivotal role, you will report directly to the Nordic General Manager and be an integral member of the Merz Therapeutics Nordic Leadership team.

**Key Responsibilities**

  • Plan and manage regulatory submissions for new or existing product registrations.
  • Ensure portfolio maintenance in compliance with national, MRP, DCP, and CP procedures.
  • Provide regulatory support to internal and external stakeholders and assist with tender management and reimbursement processes.
  • Review national documents, labeling texts, and artwork.
  • Serve as the primary regulatory contact for Merz Therapeutics Nordics AB.

**Quality Assurance**

  • Act as the Local Responsible Person (Sakkunnig Person), managing technical complaints, local ICSRs, and product quality issues in coordination with global departments and local partners.
  • Oversee and execute recall operations, engage with the global QA team on handling returned, rejected, recalled, or falsified products, and ensure corrective and preventive measures are implemented following self-inspections.
  • Prepare for, participate in, and follow up on authority audits, adapting and implementing local Periodic Safety Update Reports, Risk Management Plans, and Educational Material.
  • Implement additional Risk Minimization Measures in collaboration with global departments, and plan, execute, and report on vendor, internal, and branch audits.
  • Develop, maintain, and control Merz Therapeutics Nordics AB QA Systems, including acting as Key User for Smart Solve and managing SOP training documentation.
  • Create and coordinate internal training plans for SOPs and relevant legislation, assess local legislation for business impact, and identify necessary tasks in cooperation with other experts.
  • Record and assess product-related technical complaints with Customer Service Managers, participate in the Local Emergency Management Team, and document and report non-conformances and follow up on CAPAs from audits.
  • Host local inspections and audits from headquarters and create and report KPIs to management.

**Pharmacovigilance and Safety**

  • Maintain a local pharmacovigilance (PV) system.
  • Serve as the interface between the EU-QPPV/Global PV and local regulatory authorities.
  • Act as the primary PV contact for the local Competent Authority.
  • Maintain written PV procedures related to local tasks and obligations.
  • Conduct local signal detection activities.
  • Collaborate with Medical Manager and MSL functions and provide first-level Medical Information/Affairs support.
  • Participate in PV-relevant audits and inspections with global functions and the EU-QPPV.
  • Ensure PV training for affiliate employees, service providers, and third parties.
  • Control of superordinate projects and topics for e.g. congresses and symposia

**Requirements**

  • Bachelor's/Master's degree in Life Sciences or Pharmacy
  • Qualified Responsible Person
  • At least 5 years of experience in Drug Regulatory Affairs
  • Significant experience in early and late-stage regulatory drug development, manufacture, and commercialization.
  • Knowledge of regulatory procedures and legislation for drug development, product registration, and license maintenance
  • Familiarity with Nordic and EU regulations for medical product registrations.
  • Expertise in labeling and artwork management
  • Located in the Stockholm region, fluent in Swedish and English
  • Strong project management skills
  • Ability to work autonomously with high self-management
  • Analytical skills to simplify complex regulatory, quality, and pharmacovigilance challenges
  • Team player with a go-to personality
  • Strong work ethic and resilience
  • Confident, quick-thinking, responsive, and solution-oriented

**What We Offer**

  • Permanent employment relationship with long-term career prospects
  • High working time flexibility which enables a good work-life balance
  • Attractive location with good transport links and modern, well-equipped workplaces
  • Global family business with flat hierarchies and short decision processes
  • Collaboration in multi-functional international teams
  • Attractive compensation with comprehensive social benefits

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