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Job Title Sr. Manager Central RA

Location Bangalore India

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.

Responsibilities

Global Regulatory Strategy - Transformation and Innovation Initiatives

I. 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

II. Drive transformation initiatives to improve regulatory processes and ensure compliance with changing regulatory requirements.

III. Collaborate with cross-functional teams to identify opportunities for innovation and implement solutions.

Regulatory Submissions and Compliance

I. Lead the preparation and submission of regulatory documents including lifecycle management submissions to regulatory authorities globally.

II. Ensure that all submissions are accurate complete and compliant with regulatory requirements.

III. Engage and collaborate with cross-functional teams including R&D Quality and Manufacturing to gather necessary information and ensure alignment.

IV. 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

V. Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions

Harmonization and Standardization

I. Establish and maintain standardized regulatory processes procedures and documentation within Central RA to drive operational efficiency and regulatory compliance across GRA. Solution orientated can do work approach - Identify need for new regulatory policies procedures and SOPs when needed

II. 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.

III. Ensure compliance and audit-proofing in standardized regulatory operations - Champion regulatory compliance initiatives and quality systems improvements ensuring alignment with industry best practices.

Cross-functional Collaboration

I. 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.

II. Serve as a key advisor to senior management on global regulatory trends risks and opportunities impacting business decisions

Regulatory Intelligence and Advocacy

I. Monitor regulatory landscape and trends to anticipate changes in regulatory requirements and industry standards.

II. 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

III. 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.

Team Development and Talent Management

I. 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

II. Recruit develop and retain a high-performing team of regulatory affairs professionals fostering a high-performance culture and continuous learning environment within Central RA

III. Provide coaching training and mentorship to enhance regulatory expertise and leadership capabilities across the organization.

Key skills and competencies

Advanced knowledge of regulatory requirements and guidelines including ICH FDA EMA and other global regulatory authorities.

Strong understanding of product development lifecycle management and post-marketing activities.

Ability to analyze complex regulatory issues and develop effective solutions.

Ability to identify opportunities for innovation and implement solutions.

Exercise independent judgement with ability to identify compliance risks and necessary remediation planning

Responsible for driving strategic initiatives and transformation to improve regulatory processes and support business objectives.

Excellent communication and presentation skills with the ability to articulate regulatory strategies and influence decision-making at senior management levels.

Strong project management and organizational skills with a focus on driving results and meeting regulatory milestones

Adaptability to changing regulatory environments and market dynamics globally

Qualifications

Ø Advanced degree in Pharmacy Life Sciences Biotechnology Regulatory Affairs or related discipline.

Ø 12 years of progressive experience in global regulatory affairs within the pharmaceutical biotechnology or medical device industry with significant people management and team development

Ø Expert knowledge of global regulatory requirements and guidelines (FDA EMA TGA MHRA etc.) with a strong track record of successful regulatory submissions and approvals.

Ø Proven leadership skills with the ability to influence and collaborate effectively across diverse global teams and stakeholders.

Ø Strategic thinker with the ability to navigate complex regulatory challenges and drive regulatory initiatives that support business growth and compliance objectives.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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