Regulatory Publisher, Intern Katalyst HLS


Responsibilities:
Electronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.)
Support various internal functional groups ensuring the compliant use of eCTD Authoring Templates Primary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as required
Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications.
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Regulatory Specialist job – Katalyst HealthCares & Life Sciences – Groton, CT


April 16, 2018 – Regulatory Specialist – p b Overview: /b /p ul li Regulatory Specialist / Associate with exeperince in Medical device regulatory filings of /li li Product transfer
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Regulatory Affairs Lead Katalyst HLS


Required Skills:
Candidates who has worked in Regulatory Affairs in any Medical device companies.
Candidates who has worked in Notified Bodies such as TUV, UL, BSI, SGS, Intertek etc with exposure to Medical device regulations.
Relevant experience in Drug Safety case processing, drug safety database (e.g. ARISg or Argus), MedDRA and WHO-DRUG dictionaries
Experience with performing quality checks on SAE reports, AE/SAE reconciliations.
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Regulatory Affairs Lead Katalyst HLS


Required Skills:
Candidates who has worked in Regulatory Affairs in any Medical device companies.
Candidates who has worked in Notified Bodies such as TUV, UL, BSI, SGS, Intertek etc with exposure to Medical device regulations.
Relevant experience in Drug Safety case processing, drug safety database (e.g. ARISg or Argus), MedDRA and WHO-DRUG dictionaries
Experience with performing quality checks on SAE reports, AE/SAE reconciliations.
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Regulatory Affairs Consultant katalyst HLS


Job Description:
The Regulatory Affairs Specialist is responsible for obtaining US and OUS product clearances as well as maintaining Technical Files and Establishment Licenses.
Also, participants in worldwide Field Actions. In addition, the Regulatory Affairs Specialist communicates significant design changes outwardly to Distribution Partners, while also communicating changes in the evolving regulatory landscape inwardly to product development team.
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Regulatory Submission Specialist Katalyst HLS


DESCRIPTION:
As a central eSubmissions expert, incumbent provides direct support to global submission teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions in scope.
Incumbent manages all aspects of document workflows associated with submission authoring, review, compilation, publishing and transfer on Health Registration Submissions worldwide using specialized software tools (e.g. docuBridge, documentum).
Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.
Additionally, the incumbent performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types.
This role includes partnering with RSMP colleagues at other sites t
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Medical Device Senior Regulatory Affairs Specialist KATALYST HLS


Job Description:
Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies (directly or with customers) for Pharmaceutical/ Device Combination Products.
Collaborate with cross-functional team to support customer filing strategy and manage regulatory activities and timelines for investigational and commercialized products.
Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation that supports agreed world-wide registration timelines.
Provide CMC regulatory guidance to project teams and Global Regulatory team.
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