About the job 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 fast-paced, deadline-driven setting.

Leadership capabilities.

Note: Local candidate highly preferable. Do not apply freshers.

Education - B.pharm / M.pharm

Experience - 08 Years to 12 Years

Location - Sindhu Bhavan, Ahmedabad

Email - [email protected]

Website - www.swiss.in

📌 Regulatory Affairs Manager (Ahmedabad)
🏢 Swiss Parenterals
📍 Ahmedabad