At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Summary
Under general supervision responsible for monitoring regulations and guidance for assigned submission types and coordinating and preparing standard submissions (i.e. US Drug Annual Reports) on behalf of Global Regulatory Leads.
Essential Duties and Responsibilities
• Prepare and compile assigned standard submissions on behalf of Global Regulatory Lead within timelines required by health authority
• Maintain awareness of regulatory requirements and ensure continued learning
• Maintain regulatory files in a format consistent with requirements
• Participate as an active team member of project teams as required
• Edit and proofread regulatory documentation
• Track status and progress of regulatory documentation
• Assist in preparation, review and maintenance of role-based deliverables
• Participate in other projects as assigned
Qualifications
a. Knowledge of regulations
b. Scientific knowledge
c. Administrative and project management skills
d. Ability to contribute to multiple projects from a regulatory affairs perspective
e. Ability to multitask and prioritize
f. Interpersonal and communication skills
g. Technical system skills (e.g. word processing, spreadsheets, databases, online research)
h. Proofreading and editing skills
Education and/or Experience
Bachelor’s degree or country equivalent in relevant scientific discipline. Suitable candidates with a non-scientific degree may be accepted and undertake further training. Regulatory experience (not mandatory) preferably within a healthcare environment.
Req # JR – 110004
Location: Bengaluru, Karnataka, India
Job Category: Regulatory Affairs
Date posted: 08/28/2023
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