Manager – Regulatory Affairs (LATAM & MENA Markets) Full Time

Job Title: Manager – Regulatory Affairs (LATAM & MENA Markets)

Department: Regulatory Affairs

Location: Kurla

Company Name- AMN Life Science Pvt Ltd

Job Summary

We are seeking an experienced Regulatory Affairs Manager to lead regulatory activities for the LATAM (Latin America) and MENA (Middle East & North Africa) regions. The incumbent will be responsible for developing regulatory strategies, preparing and submitting dossiers, managing product registrations, renewals, variations, and ensuring compliance with country-specific regulatory requirements across assigned markets. The role requires close coordination with internal stakeholders, distributors, partners, and health authorities to ensure timely approvals and lifecycle management of pharmaceutical products.

Key Responsibilities

• Develop and execute regulatory strategies for product registrations, renewals, variations, and lifecycle management across LATAM and MENA markets.
• Prepare, review, compile, and submit CTD/eCTD dossiers and country-specific regulatory submissions.
• Coordinate with health authorities, local agents, distributors, and business partners for regulatory approvals and query responses.
• Manage regulatory deficiencies, agency correspondence, and approval tracking to meet business timelines.
• Monitor changes in regulatory requirements and provide regulatory intelligence to internal stakeholders.
• Ensure timely implementation of post-approval changes, renewals, label updates, and product maintenance activities.
• Collaborate with CMC, Quality Assurance, Supply Chain, Manufacturing, Business Development, and Commercial teams to support product launches and compliance activities.
• Maintain regulatory databases, approval trackers, and documentation archives.
• Support due diligence, new product evaluations, and market expansion initiatives in assigned territories.
• Manage and mentor regulatory team members and external consultants, where applicable.

Key Markets

LATAM: Brazil, Mexico, Argentina, Colombia, Chile, Peru, Central America, and other Latin American countries.

MENA: Saudi Arabia, UAE, Egypt, Jordan, Iraq, Morocco, Algeria, GCC countries, and other North African markets.

Qualification & Experience

• M.Pharm / B.Pharm / Master’s in Life Sciences or related field.
• 8–12 years of Regulatory Affairs experience in pharmaceutical companies.
• Minimum 5 years of hands-on experience handling LATAM and/or MENA markets.
• Strong knowledge of CTD/eCTD dossier preparation and submission processes.
• Experience with product registrations, renewals, variations, GMP documentation, and lifecycle management.
• Exposure to regulatory agencies such as ANVISA, COFEPRIS, INVIMA, ANMAT, SFDA, UAE MOHAP, EDA, and GCC regulatory systems is preferred.

Required Skills

• Regulatory Strategy & Compliance
• Dossier Compilation & Submission
• Regulatory Intelligence
• Project Management
• Health Authority Interactions
• Cross-functional Collaboration
• Excellent Communication & Stakeholder Management
• Strong Analytical and Problem-Solving Skills

Preferred Languages

• English (Mandatory)
• Spanish and/or Arabic (Preferred)

Salary Range- 10LPA to 12LPA

·        Interested Candidates Send your updated CV to:

·        📩 shankar.sahu@amnlife.com