Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Post : Principal Specialist, Regulatory Affairs (Hybrid)
Job Description
• 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.
• Execute global plans and regulatory submission deliverables for sustaining variations
• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
• Ensure identified standards and content requirements are met for regulatory submissions
• Timely, actively support query responses
• 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).
• 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
Candidate Profile
• Experience operating in a regulated 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 communicate and apply
• 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
• Aptitude for Attention to Detail
Additional Information
Location : Bengaluru, Karnataka, India
Industry Type : Pharma/ Healthcare/ Clinical research
Job Category : Regulatory Affairs
End Date : 30th April 2024
See All M.Sc Alerts M.Pharm Alerts Ph.D Alerts Bangalore Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
