Senior Manager, Central Regulatory Affairs Empleos

Senior Manager, Central Regulatory Affairs

Baxter

Ubicación:
India , Bangalore

Categoría:
TI - Administración

Tipo de contrato:
No proporcionado

Salario:

No proporcionado

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Descripción del trabajo:

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.

Responsabilidades:

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. This includes anticipating the implications of regulatory changes, and preparing for them, finding out the best way to register the products, and overall life cycle management
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. Communicate with team, peers and business and cross-functional leaders in a genuine, transparent way, to maximize the flow of information and drive effective collaboration
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

Requisitos:

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

Información adicional:

Oferta publicada:
14 de febrero de 2026

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Senior Manager, Central Regulatory Affairs

Baxter

Ubicación:
India , Bangalore

Categoría:
TI - Administración

Tipo de contrato:
No proporcionado

Salario:

Descripción del trabajo:

Responsabilidades:

Requisitos:

Información adicional:

Oferta publicada:
14 de febrero de 2026

¿Buscas más oportunidades? Busca otras ofertas de trabajo que coincidan con tus habilidades e intereses.

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Senior Manager, Central Regulatory Affairs

Baxter

Ubicación:India , Bangalore

Categoría:TI - Administración

Tipo de contrato:No proporcionado

Salario:

Descripción del trabajo:

Responsabilidades:

Requisitos:

Información adicional:

Oferta publicada:14 de febrero de 2026

¿Buscas más oportunidades? Busca otras ofertas de trabajo que coincidan con tus habilidades e intereses.

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14 de febrero de 2026