Require Regulatory Affairs Sr Specialist 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.

Post : Sr Specialist, Regulatory Affairs

Job Description
• Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions.
• Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals & submissions
• Track status and progress of regulatory documentation
• Coordinate and compile responses to regulatory authority questions (under supervision)
• Use an electronic document management system to compile documents to support submissions to Health Authorities
• Answer internal queries for assigned products
• Maintain Database of Regulatory Requirements for renewals
• Support other regulatory processes as required, including device establishment registration, drug listing, structured product labeling, and processing requests for certificates and legalization.

Candidate Profile
• 6 + years of regulatory experience within a healthcare environment.
• Bachelor’s degree or country equivalent in a relevant scientific discipline.
• Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.
• Knowledge of regulations
• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Proofreading and editing skills
• Ability to independently identify compliance risks and resolve or escalate as necessary

Additional Information
Experience : 6 + years
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th October 2024