Pharmaceutical Submission Expert

16 hours ago


Stockholm, Stockholm, Sweden Karo Group Full time

Karo Group, a forward-thinking company, is committed to delivering high-quality pharmaceutical products.

We are looking for a seasoned Regulatory Compliance Specialist to lead our submissions and compliance initiatives at our headquarters in Stockholm, Sweden.

About the Job:
  • Lead the Submissions & Compliance team and oversee the development of Karo medicinal products.
  • Develop strategies for submission planning and performance management.
  • Ensure compliance with regulatory requirements and oversee artwork process and eRIMS data system.
Responsibilities:
  1. Team Lead Responsibilities:
  • Pipeline management and resource allocation.
  • Coordinating Regulatory Intelligence and eCTD Publishing.
  • Budgeting and follow-up with the Head of Global Regulatory Affairs.
Portfolio Responsibilities:
  • Planning and preparation of regulatory procedures and tasks.
  • Maintaining current knowledge base of regulations, standards, and guidance documents.
  • Providing regulatory input to cross-functional teams.
Requirements:
  • University degree in Life Science or relevant field.
  • Minimum 5 years of experience in Global Regulatory Affairs.
  • Leadership qualities and extensive record of Variation management.
  • Strong working relationship with regulatory authorities.
What We Offer:
  • A dynamic and international work environment.
  • Flexible schedule and life-work balance.
  • Exciting projects with direct impact on customers and industry.
  • Opportunity to grow and develop within the company.


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