Regulatory Affairs specialist Job at Katalyst Healthcares & Life Sciences
Responsibilities:
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
- Requires a University Degree and minimum of 5 years of relevant experience, or advanced degree with 2 years of experience.
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