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.
About the Role
Job Title: Regulatory Affairs Manager / Senior Manager
Department: Regulatory Affairs
Region: LATAM (Latin America)
Product Focus: Parenteral Products (Injectables)
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).
Preferred Skills
Strong project management abilities.
Attention to detail and regulatory compliance mindset.
Ability to work in a rapid-paced, deadline-driven env