Job Description

Job Description:
• Create and Review regulatory documentation for Drug and Device 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

Qualification:
• 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
• Excellent interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Veeva Vault experience strongly preferred
• Proofreading and editing skills
• Ability to independently identify compliance risks and resolve or escalate as necessary

Relevant Experience 6-10yrs