
Regulatory Affairs Specialist
8 hours ago
Karo Group, a leading healthcare company, is committed to empowering people to make informed health decisions.
We are currently seeking a highly skilled Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs professional to join our headquarters in Stockholm, Sweden.
About the Role:- Lead the Submissions & Compliance team and oversee maintenance and 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.
- Coordinate local RA consultants and support cross-functional teams.
- 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.
- 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.
- 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.
- Experience from artwork maintenance and associated label requirements.
- Strong working relationship with regulatory authorities.
- 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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