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Head of Regulatory Affairs / QA/ Product Safety (m/f/d) Nordics

Full Time
Stockholm, Schweden
Experienced Professional
July 08, 2024
Hybrid

YOUR CONTRIBUTION

We are seeking an exceptional individual to join our team as tHead of Regulatory Affaires / QA/ Product Safety for the  Nordic region. 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. Your expertise will be crucial in shaping our regulatory strategies, ensuring pharmacovigilance, and upholding quality standards across Sweden, Norway, and Denmark. Join us to make a significant impact on patient outcomes and drive our mission forward.

 

REGULATORY AFFAIRS

  • 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 & 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

 

YOUR PROFILE  

  • 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

YOUR BENEFITS   

  • 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

 

Find out more about our global benefits here.

ABOUT US

Merz Therapeutics, founded in 1908 by chemist Friedrich Merz in Frankfurt, Germany, is a renowned specialty healthcare company with over 110 years of history. Proudly family-owned for four generations, Merz has continuously evolved, making significant strides from dental products to breakthroughs in Alzheimer’s disease. With around 700 employees across North America and Europe, and headquartered in Frankfurt am Main, Germany, Merz is dedicated to improving patient outcomes through close collaboration with healthcare partners.

Merz Therapeutics Nordics AB, established in 2023, operates with 16 employees across Sweden, Norway, and Denmark. The organization is in an exciting growth phase with one established product on the market and several others in development. Our team is supportive, engaged, and celebratory, fostering a workplace where every individual is valued and heard. We had a highly successful first year, achieving significant milestones and remarkable product growth.

For more information, visit https://www.merztherapeutics.com/se/

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