Swiss, a third-generation family-owned business, leverages over 25 years of expertise in generic and specialty pharmaceuticals. Our proficiency extends to the development and manufacturing of a diverse range of sterile dosage forms. Operating globally, we export our products under our brand name, reaching over 80 countries.
Post : Regulatory Affairs - Manager / Senior Manager
Job Summary
We are seeking a highly experienced Regulatory Affairs professional to manage regulatory activities for parenteral (injectable) products across the LATAM region. The role involves end-to-end regulatory lifecycle management, ensuring timely submissions, approvals, and compliance with regional regulatory requirements.
Responsibilities
• Develop and implement regulatory strategies for product registrations in LATAM markets.
• Prepare, review, and submit dossiers (CTD/eCTD) for new product registrations, renewals, and variations.
• Handle regulatory submissions for parenteral products in compliance with country-specific guidelines.
• Liaise with health authorities across LATAM to secure approvals within defined timelines.
• Monitor and interpret changes in regulatory requirements and ensure compliance.
• Coordinate with cross-functional teams including R&D, QA, Manufacturing, and Supply Chain.
• Manage deficiency responses, queries, and commitments from regulatory agencies.
• Maintain regulatory documentation and databases.
• Support audits and inspections related to regulatory affairs.
• Mentor and guide junior team members (for Senior Manager role).
Required Skills
• Hands-on experience with parenteral (injectable) product registrations.
• Strong knowledge of CTD/eCTD formats and submission processes.
• Familiarity with regulatory requirements of countries such as Venezuela, Uruguay, Paraguay, Guatemala, Panama, Chile, Colombia and Peru.
• Experience in handling regulatory authority queries and lifecycle management.
• Excellent communication and coordination skills.
• Proficiency in English (Spanish/Portuguese is an added advantage).
Additional Information
Experience : 07 to 10 years relevant experience
Qualification : B. Pharm / M. Pharm
Region : LATAM (Latin America)
End Date : 30th April 2026
Interested Candidates can share their resume on following email address : hroffice1@swiss.in ; hroffice@swiss.in
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