- Req # JR – 137117
- Location Bengaluru, Karnataka, India
- Job Category Regulatory Affairs
- Date posted 05/24/2024
- 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
Reasonable Accommodations
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