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Sunglow Lifescience is hiring an experienced Regulatory Affairs Manager for LATAM and CIS markets. If you have strong expertise in OSD and Ointment regulatory submissions, dossier preparation, and global compliance standards, this is a high-impact opportunity to drive international product registrations and shape global healthcare access.
This role is ideal for regulatory professionals looking to work on ANVISA, COFEPRIS, INVIMA, EAEU and other major market filings while collaborating with cross-functional pharma teams.
Key Responsibilities
Regulatory Strategy & Submissions
- Develop and implement regulatory strategies for OSD and Ointment formulations in LATAM & CIS markets.
- Prepare, review, and submit CTD/ACTD/eCTD dossiers per country regulations (Brazil-ANVISA, Mexico-COFEPRIS, Colombia-INVIMA, EAEU, etc.).
- Manage product life-cycle activities, renewals, and variations.
Compliance & Documentation
- Ensure compliance with GMP, ICH, WHO, and region-specific regulatory guidelines.
- Review and approve artworks, labels, SmPC, and patient leaflets.
- Oversee documentation for stability studies, BE requirements, and product quality modules.
Cross-Functional Collaboration & Market Intelligence
- Collaborate with QA, QC, R&D, and Supply Chain for seamless dossier readiness.
- Monitor regulatory changes across LATAM & CIS and update internal systems.
- Drive process optimization for faster, high-quality submissions.
Preferred Skills
- Conversational proficiency in Spanish or Russian.
- Experience with EAEU Module 1–5 dossier structure.
Qualifications & Experience
- Master’s degree in Pharmacy or Life Sciences.
- 8–10 years of hands-on Regulatory Affairs experience in a pharma manufacturing environment.
- Strong expertise in OSD & Ointment submissions for LATAM and CIS regions.
- Deep understanding of stability, bio-equivalence, and product quality documentation.
Why Join Sunglow Lifescience?
- Opportunity to work on global regulatory pathways.
- Dynamic, growing pharma environment.
- Exposure to diverse international markets.
- Contribute to impactful healthcare solutions.
How to Apply
Submit your updated resume to:
📧 hr_admin@sunglowlifescience.com
