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12 Vantive Jobs
Sr Specialist, Regulatory Affairs
Vantive
posted 15hr ago
Job Role Insights
Key skills for the job
Job Description
- Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions.
- Interact with non-regulatory support groups (ie, manufacturing, product stability, quality, clinical, etc) to request documentation necessary to support product renewals & submissions
- Track status and progress of regulatory documentation
- Coordinate and compile responses to regulatory authority questions (under supervision)
- Use an electronic document management system to compile documents to support submissions to Health Authorities
- Answer internal queries for assigned products
- Maintain Database of Regulatory Requirements for renewals
- Support other regulatory processes as required, including device establishment registration, drug listing, structured product labeling, and processing requests for certificates and legalization.
- 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 (eg word processing, spreadsheets, databases, online research)
- Proofreading and editing skills
- Ability to independently identify compliance risks and resolve or escalate as necessary
Suitable candidates with a non-scientific degree may be accepted and undertake further training eg under an apprenticeship or similar post graduate qualification.
Employment Type: Full Time, Permanent
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