Regulatory Affairs Manager

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 environment.
• 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 - [HIDDEN TEXT]

Website - www.swiss.in