Lead Regulatory Affairs Specialist

7 days ago

Stockholm, Stockholm, Sweden Merz Therapeutics - Europe Full time


Director of Regulatory Compliance
  • Full Time
  • Location: Nordic Region
  • With Professional Experience

YOUR ROLE

We are looking for a highly skilled professional to take on the role of Director of Regulatory Compliance for the Nordic region. In this essential position, you will report directly to the Nordic General Manager and play a key role in the leadership team at Merz Therapeutics Nordic. Your knowledge and experience will be vital in developing our regulatory frameworks, ensuring safety monitoring, and maintaining quality standards across the Nordic countries.

REGULATORY COMPLIANCE

  • Oversee and coordinate regulatory submissions for both new and existing product approvals.
  • Ensure compliance with national regulations and procedures for product maintenance.
  • Provide regulatory guidance to both internal teams and external partners, assisting with tender management and reimbursement strategies.
  • Review and approve national documentation, labeling, and promotional materials.
  • Act as the primary regulatory liaison for Merz Therapeutics in the Nordic region.

QUALITY ASSURANCE

  • Serve as the Local Responsible Person, managing product complaints and quality issues in collaboration with global teams.
  • Lead recall operations and coordinate with global QA on handling product returns and ensuring corrective actions are taken.
  • Prepare for and participate in audits from regulatory authorities, implementing necessary updates to safety reports and risk management plans.
  • Develop and maintain quality assurance systems, including training documentation and standard operating procedures.
  • Coordinate internal training initiatives on regulatory compliance and relevant legislation.
  • Document and manage product-related complaints and follow up on corrective actions from audits.
  • Facilitate local inspections and audits, reporting key performance indicators to management.

PHARMACOVIGILANCE & SAFETY

  • Maintain a robust local pharmacovigilance system.
  • Serve as the point of contact between local regulatory authorities and global pharmacovigilance teams.
  • Conduct local signal detection and collaborate with medical teams to provide support for medical inquiries.
  • Ensure compliance with training requirements for all employees and third-party service providers.

YOUR QUALIFICATIONS

  • Bachelor's or Master's degree in Life Sciences or Pharmacy.
  • Qualified Responsible Person status.
  • A minimum of 5 years of experience in Drug Regulatory Affairs.
  • Proven experience in regulatory drug development and commercialization.
  • In-depth knowledge of regulatory processes and legislation.
  • Familiarity with Nordic and EU regulations for medical products.
  • Strong project management capabilities and the ability to work independently.
  • Excellent analytical skills and a collaborative team-oriented approach.

YOUR BENEFITS

  • Permanent employment with opportunities for career advancement.
  • Flexible working hours to support work-life balance.
  • Modern work environment with excellent transport links.
  • Engagement in international teams with a collaborative culture.
  • Competitive compensation package with comprehensive benefits.

ABOUT MERZ THERAPEUTICS

Merz Therapeutics is a well-established specialty healthcare company with a rich history and a commitment to improving patient outcomes through innovative solutions. Our Nordic division is in a dynamic growth phase, focusing on enhancing our product offerings and fostering a supportive workplace culture.

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