Global Drug Safety Compliance Specialist, Process and Standards job – Katalyst HealthCares & Life Sciences – Cambridge, MA |

July 18, 2018 – GDS Compliance Process and Standards – p b Job Responsibilities: /b /p ul li Review controlled process documents to ensure submitted procedures are compliant and meet the requirements


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

Clinical Trial Specialist Kataltst HLS

Job Description:
Clinical Sciences (CS) is the bridge from preclinical research to clinical development and optimally addresses patient’s unmet needs to maximize the value of ‘s development portfolio thereby making happen “Science for a better life “.

Regulatory Submission Specialist Katalyst HLS

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

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

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

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,