Job for Regulatory Affairs Associate at Baxter

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. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Post : RA Associate, Variations Support

Job Description
Summary
This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation development and submission, product/facility change management, process support, and participation in project sub-teams.
• Review and provide regulatory documentation for submission of registration changes to global Health Authorities
• Responsible for working with other parts of the regulatory organization to 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
• Bachelor’s Degree or country equivalent in related scientific discipline
• Higher degree/PhD will be an advantage
• No regulatory experience required
• 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
• 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
Req #: 190005A2
Qualification : B.Sc, Advanced Degree / Ph.D
Location : Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Variations Support
End Date : 10th August, 2019