What are the responsibilities and job description for the Regulatory Affairs Coordinator position at Katalyst CRO?
Responsibilities
- Regulatory Labelling Documentation.
- Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions.
- Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling projects in close collaboration with GLM/GL-TAL.
- Independently coordinate the timely delivery of compliant documentation (Clinical Overviews, Nonclinical Overviews, SCE, SCS, PSUR, published literature, Expert CVs, Signature Pages, etc.) to support the regulatory labelling submissions worldwide. Order English translations of non-English literature as needed.
- Guide and support the GLM/GL-TAL, GPRD/GPRM and cross-functional experts with the review of CLP and SRP documents to ensure compliance with state-ofthe-art regulatory requirements and company standards, including formal QC.
- Independently enter and maintain current information on the labelling project in Ops RADAR including the planned global dispatch date of CLP/SRP.
- Contribute to the planning and supervision of the Phase 1 milestones for Safety Label Changes and obtain SLC Tracking Numbers from GL Compliance and Artwork Team.
- Independently prepare the Reference lists for the Core Data Sheets in compliance with current documentation standards.
- Independently exchange regulatory documents and collaborate directly with other client divisions and license partners on behalf of GLM/GL-TAL according to collaboration agreements. Monitor the GL Mailbox for new communications from license partners and forward these to the appropriate GLM/GL-TAL.
- Create and maintain GL functional and product-specific labeling archives. Global Labeling Committee.
- Independently prepare and communicate the annual schedule of GLC and Joint GLC/MSRB meetings.
- Independently coordinate with CLP authors and GPTs the scheduling of topics for GLC and Joint GLC/MSRB review and prepare/maintain the agendas of GLC and Joint GLC/MSRB meetings.
- Organise the logistics of GLC and Joint GLC/MSRB meetings and distribute meeting invitations with pre-reads to the GLC (and MSRB, if applicable) members.
- Pro-actively ensure that CLP authors and GPTs prepare program-team-agreed draft contributions to the GLC and Joint GLC/MSRB meeting minutes and manage the workflow of GLC Chair review/input, GLC(/MSRB) review, finalization, distribution and archiving of the meeting minutes.
- Independently coordinate the timely off-line GLC review of appropriate labeling changes as agreed with the GLC Chair, compile and archive the feedback received.
- Exchange planning information and documentation directly with the members of the GLC, MSRB, GPTs as needed.
- Excellence and Compliance.
- Contribute to global labeling management and continuous improvement initiatives. Review and comment on emerging internal process documents and labeling standards.
- Ensure compliance of CLPs with global regulatory labeling requirements and adherence to regulatory internal policies and processes.
- Provide adequate support during HA inspections and own or foreign company audits, such as compiling and archiving documentation, etc..
- Act as administrator and superuser for regulatory and labeling-specific databases.
- Organize and lead as subject matter expert tutorial training sessions for RA GL newcomers.
- Provide administrative support to GLM, GL-TAL and Head GL as needed.
- Minimum of 3 - 5 years of related pharmaceutical / regulatory affairs experience.
- Prior publishing/Regulatory Operations experience beneficial.
- Good communication and negotiation skills.
- Proactive personality.
- Fast and flexible, focused on high quality and timely delivery and stretch targets
- Ability to plan and prioritise workload
- Ability to work in a matrixed environment.
- Ability to build effective relationships across teams/projects.
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