
Bioequivalence Regulatory Affairs Expert
3 days ago
Job Opportunity
We are seeking a skilled Regulatory Affairs Professional to manage regulatory activities for biosimilar products in the emerging LATAM market.
This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations.
Main Responsibilities:
- Develop and implement effective regulatory strategies for biosimilar products in LATAM.
- Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements.
- Evaluate and implement regulatory changes impacting product lifecycle.
- Manage post-approval activities including labeling updates, renewals, and change control assessments.
- Maintain up-to-date knowledge of LATAM regulatory guidelines.
- Liaise with local health authorities, business partners, and internal teams.
Requirements
- Minimum 4 years of experience in Regulatory Affairs within the pharmaceutical/biotech industry.
About the Role
This is an exciting opportunity to join our team as a Regulatory Affairs Specialist. If you have a passion for regulatory affairs and a desire to work in a dynamic environment, we encourage you to apply.
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