Senior Manager - Regulatory Affairs

Roles & Responsibilities:
• Develop and implement global regulatory strategies for Drugs and Medical Devices across product lifecycle (Initial registrations, Geo-expansion, Variations, Change Controls, Tender support, Legal entity updates, etc.)
• Lead global lifecycle management submissions ensuring timely approvals and compliance across multiple markets
• Drive regulatory transformation and innovation initiatives to enhance operational efficiency
• Establish and standardize regulatory processes, SOPs, and documentation within Central RA
• Ensure audit readiness and compliance with global regulatory standards
• Collaborate with R&D, Clinical, Quality, Manufacturing, Legal, and Commercial teams to integrate regulatory requirements into business strategy
• Monitor global regulatory intelligence and proactively address evolving regulatory changes
• Represent the organization before health authorities, regulatory agencies, and industry associations
• Identify compliance risks and implement remediation strategies
• Lead, mentor, and develop high-performing regulatory teams fostering a strong performance culture
• Act as a strategic advisor to senior management on regulatory risks, trends, and opportunities

Qualification:
• Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.pharm)
• Advance degree of Life Sciences, Biotechnology, Regulatory Affairs, or related field

Experience:
• 12+ years of experience in Global Regulatory Affairs (Pharma / Biotech / Medical Devices)
• Extensive experience in global regulatory submissions and lifecycle management
• Experience handling both drug and device regulatory requirements
• Exposure to regulatory transformation and process harmonization initiatives
• Strong track record of successful approvals across global markets

Skills:
• Strong knowledge of global regulatory agencies such as US FDA, EMA, MHRA, TGA, and ICH guidelines
• Proven leadership and people management experience
• Advanced knowledge of global regulatory frameworks and compliance requirements
• Strategic thinking with strong problem-solving ability
• Strong leadership, stakeholder management, and cross-functional collaboration skills
• Ability to manage complex regulatory environments across diverse markets
• Strong project management and organizational skills
• Excellent communication and presentation skills
• Ability to drive innovation and continuous improvement in regulatory operations

About the Organization:
Baxter International is a global healthcare leader committed to saving and sustaining lives. Founded in 1931, the company delivers innovative medicines and medical products worldwide, driven by a strong culture of integrity, collaboration, and patient-focused innovation.