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Job Title – Manager, Central Regulatory Affairs (GRA)

Location –Bangalore, India

The Manager - Central RA is a pivotal mid-level leadership role based out of Bangalore, India. This role is responsible for leading the regulatory team for support on various activities for on-market products.

Activities include Driving of Change Control Management, Co-ordination of Variation Support for Global Baxter Portfolio, Change management, Process support, and Participation in Project execution strategy. Lead cross-functional teams to Manage CCM/Variation Support, standardize, harmonize and enable Best Practices across all Businesses.

The role involves understanding global procedures and harmonizing regulatory operations across multiple business segments, regions and markets globally. The role is focused on regulatory execution, timely deliverables, compliance, and team readiness. This position requires expertise in global regulatory requirements, project management, and ability to drive efficiency through harmonized frameworks.

Responsibilities

•  Lead the team for preparation, 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.

•  Standardize and harmonize processes across all Segments for all On-market products of Global Baxter Portfolio, Initiate, Manage and Collaborate towards Variation related activities across all Segments for all On-market products of Global Baxter Portfolio

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• Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions. Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results. Ensure identified standards and content requirements are met for regulatory submissions
• Identify and prioritize key areas of risk and probability of occurrence as well as ensuring implementation of mitigation plans and follow ups
  • Assess the Teams Performance and Potential as per Organization arrangement. Monthly Check-in with team member to provide constructive meaningful and timely feedback
  • Provide direct supervision of individuals including mentoring, performance management and staffing decisions
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  • Review and provide regulatory impact assessments for changes, Support global submission deliverables for product variation submissions
  • Responsible for working with other parts of the regulatory organization to achieve desired results. Plan and manage complex projects and prioritize workload
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  • Represent Baxter interests in Industry and working groups - actively support query responses
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  • Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements. Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).
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  • Maintain regulatory files in a format consistent with requirements - Tracking of status, quality/compliance and progress of regulatory documentation. Review, edit and proofread regulatory documentation
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  Key skills and competencies

   
  • Ability to Lead, coach and motivate others
  • Ability to accomplish results through others
  • Demonstrate excellent Interpersonal and collaboration skills , including diplomacy to negotiate conflicting priorities
  • Ability to oversee multiple projects in a matrix work environment
  • Technical and Management Skills
  • Ability to work effectively in multinational/multifunctional environment.
  • Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
  • Exercise independent judgement - Scientific knowledge and ability to discuss technical matters with cross-functional team members
  • Knowledge of regulations and ability to identify compliance risks and escalate when necessary
  • Excellent verbal and written English communication skills, suitable for multi-location working relationships
  • Demonstrated teamwork and collaboration skills
•      Qualifications 
  • Master’s Degree or country equivalent in related scientific discipline
  • Higher degree/PhD will be an advantage
  • Minimum 8-10 years of progressive regulatory experience in healthcare environment
  • Expert knowledge of global regulatory requirements and guidelines (FDA, EMA, TGA, MHRA, etc.), with a strong track record of successful regulatory submissions and approvals

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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