Baxter International Inc. (Baxter) is a medtech company that has been making medical innovations for almost a century. The company was founded in 1931 by Dr. Ralph Falk and Dr. Don Baxter, and was the first commercial manufacturer of prepared IV solutions. Baxter’s products and therapies are used in hospitals, clinics, and homes, and include diagnostic, critical care, kidney care, nutrition, hospital, and surgical products.
Baxter International Inc. is Hiring Freshers
Regulatory Affairs
Designation ⏩ Regulatory Affairs Specialist
Location ⏩ Bengaluru, Karnataka, India
Req ⏩ JR – 137117
Mode Of Work ⏩ WFO
JOB Type ⏩ Full Time
Educational Qualification ⏩ B. Pharm/ M. Pharm / B.Sc. / M.Sc. / life sciences graduate
Experience needed ⏩ Freshers
Job Description:
- Create and Review regulatory documentation for Drug, Device and Combination product renewals.
- Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals
- Track status and progress of regulatory documentation that will be used for renewals
- Coordinate and compile responses to regulatory authority renewal questions (under supervision)
- Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities
- Answer internal queries for assigned products
- Maintain Database of Regulatory Requirements for renewals
- 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
Interested and Eligible candidates can apply online by link given below.
