Regulatory Compliance Manager

4 days ago


Stockholm, Stockholm, Sweden Karo Group Full time

Karo Group is dedicated to providing exciting and challenging projects that impact customers and the industry.

As a leader in Global Regulatory Affairs, you will be responsible for managing resources effectively to drive the maintenance and development of Karo medicinal products.

Job Title: Team Lead Pharma Submissions & ComplianceKey Responsibilities:
  • Lead the Submissions & Compliance team, ensuring personnel have the necessary competence for their roles.
  • Manage resources effectively to drive the maintenance and development of Karo medicinal products.
  • Allocate tasks and oversee the management of Submissions & Compliance activities, including strategies, submission planning, and performance monitoring.
  • Ensure compliance with artwork processes, eRIMS data system archiving, and relevant regulatory requirements.
  • Coordinate Regulatory Intelligence and support local RA consultants to ensure adherence to local regulations.
  • Serve as the primary contact for eCTD Publishing and collaborate with the Head of Global Regulatory Affairs on follow-up tasks.
Portfolio Accountabilities:
  • Develop and maintain a comprehensive understanding of existing and emerging regulations, standards, and guidance documents.
  • Provide regulatory input to cross-functional teams and projects, ensuring timely and adequate planning, preparation, and submission of regulatory procedures.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Coordinate subsidiaries, partners, and consultants on applicable market(s) and ensure Product Information translations are up-to-date.
Requirements:
  • University degree in Life Science or equivalent.
  • Minimum 5 years of experience in Global Regulatory Affairs, preferably in a leadership role.
  • Proven track record of formal or informal leadership qualities, variation management, and artwork maintenance.
  • Experience with National procedure, DCP, and MRP within the European Union, as well as global RA experience.
  • Strong working relationship with regulatory authorities and excellent communication skills.
What We Offer:
  • A competitive salary package and opportunities for growth and development.
  • A flexible schedule and life-work balance.
  • Exciting and challenging projects that impact customers and the industry.
  • A positive work environment in a dynamic, international, and motivated team.
  • Start-up spirit while being part of a large international organization with strong values.


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