Pharmaceutical Submissions Specialist

4 days ago


Stockholm, Stockholm, Sweden Karo Group Full time

Karo Group is committed to creating a diverse and inclusive environment where qualified candidates from all backgrounds are welcome to apply.

Our core belief in empowering people to make informed health decisions drives our growth strategy, combining organic expansion and strategic partnerships.

Job Title: Team Lead Pharma Submissions & ComplianceKey Objectives:
  • 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 budgeting and 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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