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
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 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 “.
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
• 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
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
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,