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.


Regulatory CMC specialist KATALYST HLS

Job Duties:
• Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
• Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers
• At least a Bachelor Degree required. Master’s Degree or PhD preferred

Clinical Regulatory Affairs Associate Katalyst HLS

This position interacts with multiple departments, as appropriate, involved in regulatory submissions.
The position, under supervision of the manager, makes FDA submissions, reviews requisite/critical documents and reports for completeness and suitability for submission.
Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA.
Request missing and/or illegible pages, arrange for translations as needed.
Review regulatory documents to assure FDA requirements are met and are ready for submission.
Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies.


Senior Quality / Regulatory Specialist Katalyst HLS

candidate who has strong experience in In-vitro Diagnostic (IVD) domain.
Candidate should have min of 6-8 yrs of experience and at least 5 yrs of experience in IVD domain
Should be knowledgeable on new EU regulations for IVDR


Project Manager (Regulatory affairs, Medical devices) katalyst HLS

Primary Responsibilities and Duties:
Determine and communicate deliverables and deadlines to business unit core project teams to ensure accurate expectation setting/planning, such as any required documentation, sample types and quantities needed, expected completion dates for any deliverables. In cases of expedited requests, work with the necessary group managers to agree on accelerated timeline/strategy.
Work with toxicologists and group managers to ensure test plans are developed to meet project goals. Create, organize, and maintain hard copy testing project files and electronic database.
Monitor progress of upcoming and ongoing projects. Provide customers, and internal management with progress reports and/or status updates. Promptly identify issues or delays and work with affected personnel to resolve issues and communicate any changes in strategy or timelines.


Regulatory Affairs Manager job – Katalyst HealthCares & Life Sciences – San Francisco, CA

March 2, 2018 – Regulatory Affairs Manager – p b Job Description /b b : /b /p ul li Provides tactical and strategic regulatory leadership to the organization and oversees regulatory


Regulatory Manager Specialist job – Katalyst HealthCares & Life Sciences – Bridgewater, NJ

March 2, 2018 – Regulatory Manager Specialist – p b Job Description: /b /p ul li Responsible for writing drug regulatory submissions/licenses including New Drug Application (NDA), ANDA’s,