Regulatory Life Cycle Manager Medicinal Products Specialist
1 day ago
Job Summary:
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at Jobs in Science. As a Regulatory Life Cycle Manager Medicinal Products, you will be responsible for building and maintaining medicinal product capability within our organization.
Key Responsibilities:
- Build and maintain medicinal product capability within Regulatory Affairs Life Cycle Management
- Coordinate with local regulatory affairs for variations, renewals, and answering health authority requests
- Maintain global master dossiers and compile, review, and provide dossiers for local registration and compliance
- Advise the organization on potential regulatory risks and recommend compliant actions
- Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking system
- Ensure the Veeva Regulatory Information Management system is maintained and updated for all activities under role responsibility
Requirements:
- Initial regulatory affairs experience (1-2 years), preferably in consumer health and across multiple regulatory classification areas
- Strong motivation for dossier maintenance and product change management
- Skilled in working with complex regulatory databases
- Demonstrated ability to work independently in a matrix environment to build superior relationships with stakeholders
- Organizational skills and solution-oriented attitude to handle a complex product-country portfolio
What We Offer:
- A dynamic and supportive work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
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