Regulatory Affairs Specialist
Company: Katalyst Healthcares & Life Sciences
Posted on: January 26, 2023
- Manages dossier compilation and publishing for assigned
product(s) or projects in accordance with timelines established by
Regulatory Affairs Licensing Product management to meet global
- Tracks and updates management regarding regulatory submission
- Assembles, formats, publishes, and archives Regulatory
registration dossiers/product development applications (e.g., BLAs,
MAAs, NDSs, NDAs, PMAs, 510(k)s, INDs/CTAs, Orphan Drug
Applications, etc.), and life-cycle management submissions
(supplements, variations, amendments) for Canada, US, ICON/ROW and
EU. Creates hyperlinks/cross-references/bookmarks, as necessary,
- Assists in the drafting, implementation, and revision of
internal regulatory business practices (IBPs) and procedures
(SOPSs) pertaining to paper and electronic publishing and
- Ensures compliance with regulatory agency rules and guidelines
for paper and electronic submissions. Provides update to internal
documentation, as appropriate. Prints paper dossier or burns CD/DVD
for submissions, manages shipment (e.g., Fed Ex, DHL) and tracking
- Responsible for data entry, filing, archiving and maintenance
of submission tracking databases for all outgoing/incoming
communication with regulatory agencies.
- Update tracking/notification databases and spreadsheets.
Assists in piloting new submission platforms/tools, processes
- Ideally should have e-submissions and regulatory information
management experience. Basic knowledge of applicable laws and
- Familiarity with electronic regulatory publishing and
submissions software. Superior skills with the use of MS-Word,
Adobe Acrobat and Adobe plug-in tools.
- Flexible and adaptable to changing situations within the
company/industry. Ability to work independently with limited
- High degree of attention to detail and troubleshooting skills.
Ability to meet tight project timelines.
Keywords: Katalyst Healthcares & Life Sciences, Cary , Regulatory Affairs Specialist, Other , Cary, North Carolina
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