Regulatory Affairs Specialist
Description
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Jolife AB
As a Regulatory Affairs Specialist with approximately 3 years of experience, you will support regulatory activities across the product lifecycle, ensuring compliance with local, regional, and global regulations. You will contribute to submissions, postmarket requirements, and regulatory documentation, while collaborating with cross-functional teams.
Key Responsibilities
Support the preparation and maintenance of regulatory documentation, including licenses, registrations, and product listings
Help ensure postmarket regulatory requirements are met, including compiling and submitting required reports and supplemental dossiers
Contribute to the preparation and submission of notifiable changes to regulatory authorities
Assist in reporting product safety issues in accordance with applicable regulations
Provide documentation and support for product reimbursement requests
Support regulatory input during inspections and audits
Monitor regulatory intelligence and assist in summarizing key updates for internal teams
Collaborate with cross-functional teams to support regulatory compliance throughout the product lifecycle
Assist in identifying regulatory requirements and potential obstacles for market access and distribution
Help evaluate proposed products for regulatory classification and submission pathways
Participate in the preparation of regulatory submissions and monitor review progress