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.
- Vacancy details:
- Department : Associate, RA
- Qualification: M. pharm (Regulatory Affairs)
- Experienced: 0-2 years
Job Description: Greeting from Baxter Pvt Ltd !!!!
Important Details :
- Location : Bengaluru, Karnataka, India
- Post of date 21/10/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Job Summary
As a Global Regulatory Affairs – Associate, you are responsible for providing regulatory support for change assessments, submission preparation for product registrations and submitting regulatory dossiers using various publishing tools. Supporting various phases of product life cycle, generate capability towards fundamental global regulatory requirements and different regulatory pathways. Collaborating with cross-functional teams within the organization, including R&D, quality assurance and manufacturing departments. Ability to take ownership of tasks and deliver without supervision while using their expertise to seek help when necessary.
What you’ll be doing
Engage with Global and Regional regulatory teams located across the globe to ensure regulatory activities are aligned to business needs.
Supporting stakeholders in managing product registrations and ensuring high quality submissions to Regulatory Authorities.
Responsible for Regulatory Product Life Cycle Management Activities.
High Proficiency in Trackwise8 to handle Change Control Process and RIMS-Veeva Vault for Regulatory Submissions
Tracking of status and progress of regulatory filings
Maintenance of Regulatory systems, trackers and databases.
What you’ll bring
Post graduation degree in M. pharm (Regulatory Affairs) from a reputed institution with 0-2 years of relevant experience.
Sound understanding of ICHÂ regulatory requirements and Health authority guidelines.
Must possess strong analytical thinking, and excellent organizational and communication skills.
Candidate must be able to work in a team-oriented, fast-paced environment.
Strong technical skills (Excel, Microsoft word, Databases).
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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