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 - [Confidential Information]
Website - www.swiss.in
