Job Title: Specialist- Regulatory Affairs
Company: Baxter
Location: Bengaluru, Karnataka, India
Experience: 1 to 2 years
Qualifications: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Salary: ₹25,000 – ₹35,000 per month
Job Description:
Baxter seeks a Specialist in Regulatory Affairs to create and review regulatory documentation for drug, device, and combination product renewals. The role involves interaction with support groups, tracking document status, and coordinating regulatory responses.
Responsibilities:
| Key Responsibilities | Details |
|---|---|
| Create and review regulatory documentation | For drug, device, and combination product renewals. |
| Interact with support groups | Request necessary documentation from manufacturing, product stability, quality, clinical, etc. |
| Track documentation status | Monitor the progress of regulatory documents used for renewals. |
| Coordinate regulatory responses | Compile responses to regulatory authority questions under supervision. |
| Use electronic document management systems | Compile documents for submission to Health Authorities. |
| Answer internal queries | Provide information for assigned products. |
| Maintain regulatory requirements database | Keep a database of regulatory requirements for renewals. |
Qualifications:
- Knowledge of regulations and scientific principles.
- Strong administrative and project management skills.
- Ability to contribute to multiple projects from a regulatory affairs perspective.
- Ability to multitask and prioritize effectively.
- Excellent interpersonal and communication skills.
- Proficient in technical systems (e.g., word processing, spreadsheets, databases, online research).
- Strong proofreading and editing skills.
- Ability to independently identify compliance risks and resolve or escalate them as necessary.
Skills:
- Experience in creating and reviewing regulatory documentation.
- Effective interaction with cross-functional teams.
- Proficiency in tracking and managing regulatory document status and progress.
- Competence in coordinating responses to regulatory authority questions.
- Familiarity with electronic document management systems.
- Strong organizational skills to maintain regulatory requirement databases.
- Ability to manage multiple priorities and projects simultaneously.
- Excellent written and verbal communication skills.
Apply now to join Baxter, where your purpose accelerates our mission to save and sustain lives.
