Head of Regulatory Affairs

1 month ago

Stockholm, Stockholm, Sweden Merz Therapeutics - Europe Full time
Head of Regulatory Affairs / QA/ Product Safety (m/f/d) Nordics

We are seeking an exceptional individual to take on the role of Head of Regulatory Affairs / QA/ Product Safety for the Nordic region. In this pivotal position, 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.

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 & 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
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.

  • Head of Regulatory Affairs

    3 weeks ago

    Stockholm, Stockholm, Sweden Holmen Full time

    Är du en strategisk tänkare som trivs med att navigera i komplexa politiska och regulatoriska landskap?Då är du välkommen att söka tjänsten som Head of Regulatory Affairs hos oss på Holmen.Din nya arbetsplatsHolmens koncernhuvudkontor är beläget på Strandvägen i Stockholm. Här jobbar experter och specialister inom hållbarhet, kommunikation,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Stockholm, Stockholm, Sweden ProPharma Group Full time

    ProPharma Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in Stockholm or Lund. As a Senior Regulatory Consultant, you will work on projects from various Pharmaceutical companies, dealing with challenging tasks that require result orientation and excellent interpersonal skills.The role involves working with Regulatory...

  • Head of Regulatory Affairs and Quality Assurance

    4 weeks ago

    Stockholm, Stockholm, Sweden Merz Therapeutics - Europe Full time

    Regulatory Affairs and Quality Assurance ExpertWe are seeking an experienced Regulatory Affairs and Quality Assurance professional to join our team at Merz Therapeutics Nordics AB. As a key member of our Nordic Leadership team, you will play a crucial role in shaping our regulatory strategies, ensuring pharmacovigilance, and upholding quality standards...

  • Regulatory Affairs Specialist

    2 months ago

    Stockholm, Stockholm, Sweden Länsförsäkringar Skaraborg Full time

    Job Description**About the Role**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Länsförsäkringar Skaraborg. As a key member of our organization, you will play a crucial role in ensuring compliance with regulatory requirements and developing strategies to mitigate risks.Key ResponsibilitiesCoordinate and implement...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Stockholm, Stockholm, Sweden ProPharma Group Full time

    Join Our Team as a Senior Regulatory ConsultantAt ProPharma Group, we are committed to delivering exceptional consulting services to the pharmaceutical industry. As a Senior Regulatory Consultant, you will play a critical role in helping our clients navigate the complex regulatory landscape in the Nordic region.About the RoleWe are seeking a highly...

  • Regulatory Affairs Specialist

    4 weeks ago

    Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) Full time

    About the PositionWe are seeking a highly organized and detail-oriented Regulatory Affairs Support Specialist to join our QA/RA team at RaySearch Laboratories AB (publ). As a key member of our team, you will be responsible for ensuring high data quality in our customer database, sending and following up on vigilance reports to authorities, and assisting the...

  • CMC Regulatory Affairs Specialist

    1 month ago

    Stockholm, Stockholm, Sweden QRIOS Full time

    About the RoleWe are seeking a highly skilled CMC Regulatory Affairs Associate to join our team at QRIOS Life Science. As a key member of our CMC Regulatory Business Development Team, you will be responsible for providing support to Chemistry, Manufacturing and Control (CMC) regulatory contributions required for the management of Product Divestments to 3rd...

  • Regulatory Affairs Specialist

    1 month ago

    Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) Full time

    About RaySearch Laboratories AB (publ)RaySearch develops innovative software solutions to improve cancer care. With over 1000 clinics in more than 40 countries using our software, we strive to make the best cancer treatments available for patients worldwide.About the PositionWe are seeking a highly organized and detail-oriented Regulatory Affairs Support...

  • Senior Regulatory Consultant

    3 weeks ago

    Stockholm, Stockholm, Sweden ProPharma Group Full time

    ProPharma Group is seeking a Senior Regulatory Consultant to join its Regulatory Affairs Division. The successful candidate will work on projects from various Pharmaceutical companies, dealing with challenging and varied tasks that require result and client orientation, as well as excellent interpersonal skills.The role will involve working with Regulatory...

  • Hållbarhetsstrateg

    3 weeks ago

    Stockholm, Stockholm, Sweden Holmen Full time

    Holmens huvuduppgiftHolmen söker en erfaren och strategiskt tänkande Head of Regulatory Affairs som kan stödja företagets långsiktiga affärsstrategi i en snabbt föränderlig värld.Om rollenI rollen som Head of Regulatory Affairs är det ditt uppdrag att följa och analysera utvecklingen av politiska beslut, nationellt och internationellt, för att...

  • Tax Compliance Regulatory Counsel

    1 month ago

    Stockholm, Stockholm, Sweden Sovos Compliance Full time

    About Sovos ComplianceSovos Compliance is a global leader in tax, compliance, and trust solutions. Our purpose-built software platform provides an unparalleled level of integration with business applications and government compliance processes.Job Title: Regulatory Liaison Counsel - ISVs and Embedded PartnersWe are seeking a highly skilled Regulatory Liaison...

  • Regulatory Risk Governance Expert

    7 days ago

    Stockholm, Stockholm, Sweden Nordea Bank Full time

    At Nordea Bank, we are seeking a seasoned Regulatory Risk Governance Expert to join our Compliance Risk Governance team. This role offers an exciting opportunity to leverage your expertise in regulatory analysis and risk management to drive compliance excellence.About the RoleWe are looking for a highly skilled professional with a strong background in...

  • Nordics Medical Affairs Professional

    3 weeks ago

    Stockholm, Stockholm, Sweden CSL Full time

    About the RoleThe Nordics Medical Affairs Professional will be responsible for developing and executing medical strategies in the Nordic region. This includes working closely with internal and external stakeholders to identify key opportunities and develop targeted initiatives to improve public health outcomes.Key ResponsibilitiesDevelop and execute medical...

  • Compliance Officer

    4 weeks ago

    Stockholm, Stockholm, Sweden AXA Group Full time

    Job Title: Compliance OfficerWe are seeking a highly skilled Compliance Officer to join our team in Stockholm, Sweden. As a key member of our legal and compliance function, you will play a critical role in developing and driving our compliance program for the Nordic region.Key Responsibilities:Work closely with the Head of Compliance and Regulatory Affairs,...

  • Compliance Risk Manager

    4 days ago

    Stockholm, Stockholm, Sweden AXA Group Full time

    Discover Your OpportunityWe are seeking a skilled Compliance Risk Manager to join our team in Stockholm, Sweden. In this role, you will be responsible for developing and driving our compliance function for the Nordic countries.You will work closely with the Head of Compliance and Regulatory Affairs, Europe and the Legal Counsel, Nordic Region to implement...

  • Senior Risk Expert, Model Risk Regulation Lead

    1 month ago

    Stockholm, Stockholm, Sweden Nordea Bank Full time

    Job Opportunity:We are seeking a Senior Risk Expert, Model Risk Regulation to lead our Model Risk team's role in interpreting and applying regulations related to models used in Nordea. The successful candidate will be responsible for managing engagement with regulators on model risk matters on behalf of the Model Risk team.About the Role:The Senior Risk...

  • Head of IT Infrastructure

    4 weeks ago

    Stockholm, Stockholm, Sweden Intrum Full time

    At Intrum, we're seeking a visionary leader to drive our IT infrastructure strategy and development. As the Head of IT Infrastructure, you'll oversee all aspects of our IT environment, ensuring reliability, scalability, and security. Your leadership will be key in enabling our business to thrive in a competitive landscape.Key Responsibilities:Develop and...

  • Head of Anti-Money Laundering

    1 month ago

    Stockholm, Stockholm, Sweden Qliro Full time

    About the RoleWe are seeking an experienced professional to lead our Anti-Money Laundering (AML) efforts at Qliro. As Head of AML, you will be responsible for developing and implementing effective AML strategies to prevent financial crime and ensure compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement AML policies, procedures,...

  • Head of IT Infrastructure

    1 month ago

    Stockholm, Stockholm, Sweden Intrum Full time

    Join Our Team as a Visionary IT Infrastructure LeaderWe are seeking a highly skilled and experienced IT Infrastructure professional to lead our team and drive our infrastructure strategy and development. As the Head of IT Infrastructure, you will be responsible for overseeing all aspects of our IT infrastructure, including data centers, networks, servers,...

  • Head of Architecture

    1 month ago

    Stockholm, Stockholm, Sweden Qliro Full time

    Join Qliro's Team as a Head of ArchitectureWe are seeking a highly skilled and experienced Head of Architecture to lead our technical teams and drive the development of our technology stack. As a key member of our leadership team, you will be responsible for shaping our architectural vision and ensuring that our systems are scalable, secure, and aligned with...