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Senior Manager, Central Regulatory Affairs

https://www.baxter.com/ Logo

Baxter

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Location:
India , Bangalore

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

The Sr. Manager - Central RA is a pivotal senior leadership role based out of Bangalore, India responsible for overseeing and harmonizing regulatory strategy, compliance, and operations across multiple Business segments, regions and markets globally. The role is focused on strategic regulatory oversight, compliance, and team leadership. This position requires deep expertise in global regulatory requirements, strategic thinking, strong leadership capabilities, and the ability to drive regulatory excellence and efficiency within a centralized and standardized framework.

Job Responsibility:

  • Develop and implement global regulatory strategies for Baxter products (both Drugs and Devices) aligned with business objectives to support product lifecycle spanning timely Initial /Geo-expansion/ Change controls and Variations registrations enabling speedy commercialization across diverse markets
  • Drive transformation initiatives to improve regulatory processes and ensure compliance with changing regulatory requirements
  • Collaborate with cross-functional teams to identify opportunities for innovation and implement solutions
  • Lead the preparation and submission of regulatory documents, including lifecycle management submissions, to regulatory authorities globally
  • Ensure that all submissions are accurate, complete, and compliant with regulatory requirements
  • Engage and collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to gather necessary information and ensure alignment
  • Oversee the preparation, review, and submission of both Drug and Device Lifecycle management regulatory filings (e.g., Initial and Geo-expansion registrations, change controls, Variations, Tender support, Acquisition Integration /Divestiture related Legal Entity name changes etc.) to health authorities across global markets
  • Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions
  • Establish and maintain standardized regulatory processes, procedures, and documentation within Central RA to drive operational efficiency and regulatory compliance across GRA
  • Generate future readiness with implementation of best practices and continuous improvement initiatives to optimize regulatory operations and ensure consistency across regions for registrations, Change Control Management, tender Support, Geo-expansion/Initial registrations
  • Ensure compliance and audit-proofing in standardized regulatory operations - Champion regulatory compliance initiatives and quality systems improvements, ensuring alignment with industry best practices
  • Collaborate closely with global cross-functional teams, including R&D, Clinical Development, Quality Assurance, Legal, and Commercial functions, to integrate regulatory requirements into product lifecycle management and business strategies
  • Serve as a key advisor to senior management on global regulatory trends, risks, and opportunities impacting business decisions
  • Monitor regulatory landscape and trends to anticipate changes in regulatory requirements and industry standards
  • Possess the ability to come up with solutions to deal with a heterogeneous regulatory environment
  • Represent the organization in interactions with external stakeholders – Subject matter experts/ regulatory / export / port agencies and industry associations, advocating for regulatory strategies and submissions as needed
  • Live the company Culture & core values and drive a positive team culture where team members feel valued, empowered and developed
  • Recruit, develop, and retain a high-performing team of regulatory affairs professionals fostering a high-performance culture and continuous learning environment within Central RA
  • Provide coaching, training, and mentorship to enhance regulatory expertise and leadership capabilities across the organization

Requirements:

  • Advanced degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related discipline
  • 12+ years of progressive experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with significant people management and team development
  • Expert knowledge of global regulatory requirements and guidelines (FDA, EMA, TGA, MHRA, etc.), with a strong track record of successful regulatory submissions and approvals
  • Proven leadership skills with the ability to influence and collaborate effectively across diverse global teams and stakeholders
  • Strategic thinker with the ability to navigate complex regulatory challenges and drive regulatory initiatives that support business growth and compliance objectives

Additional Information:

Job Posted:
February 14, 2026

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