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Regulatory Affairs Officer - Pharmaceuticals
Eingestellt von Elevate Direct
Gesuchte Skills: Support
Projektbeschreibung
REGULATORY AFFAIRS OFFICER/BEERSE, BELGIUM/7 MONTHS CONTRACT/38 TO 48 EUR (PER HOUR)
THE ROLE
This position is responsible for the management and delivery of regulatory submissions required to support the development, registration, and compliance of products. Depending on the particular project and assigned submission(s).
Establishing Dossier Plans for the assigned submission types/projects considering inputs from functional area representatives and key stakeholders.
Maintaining effective interactions with relevant stakeholders and other RSMO colleagues as appropriate to ensure priority conflicts, resource issues and deviations from the plans are identified and resolved.
Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
Monitoring the effectiveness of appropriate submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality.
Meeting regularly with submission stakeholders to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
Interfacing with cross-functional representatives as appropriate to manage the dossier preparation process and ensure all aspects of the plan are coordinated and executed efficiently.
Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable.
Tracking submission events/activities in appropriate systems/tools.
PRINCIPAL RESPONSIBILITIES:
These responsibilities, including complexity and scope of submissions, may vary depending on role of employee and may include but are not limited to the following:
Manage preparation and/or publishing of submissions across the product lifespan in line with Regulatory strategy.
Partner across GRA and functional area contributing groups as needed for assigned projects.
Establish the Dossier Plan(s) for the life cycle submissions considering inputs from functional area representatives and key stakeholders.
Establish and maintain effective interactions with key partners as appropriate to ensure priority conflicts, resource issues and deviations from the plan are identified and resolved.
Ensure that all required documents are included in the dossier.
Track submission events/activities in appropriate systems/tools.
Liaise with RSMO staff as required.
Support development of departmental work practices, process enhancements/improvements, and associated training materials.
Monitor the effectiveness of the submission process and initiate changes within the scope of decision making authority to minimize inefficiencies and ensure/improve quality.
Represent RSMO function on Janssen initiatives where appropriate.
Develop/maintain associated process tools and relevant training documentation.
Support compliance needs as appropriate. May have following publishing activities as defined by the particular role or job function.
Determine the scope of the electronic publishing requirements for the dossier
Utilize current electronic document management and publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions with a high degree of independence
Provide component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (eg, bookmarking, linking, PDF version, etc.)
Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements
QC electronic and paper submissions to ensure compliance with company and applicable health agency requirements
Maintain openly, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission
Participate on special projects and process improvement initiatives, as needed
Cultivate ongoing effective relationships with publishing contributors across LSM and RA Therapeutic Areas
THE COMPANY
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
THE ROLE
This position is responsible for the management and delivery of regulatory submissions required to support the development, registration, and compliance of products. Depending on the particular project and assigned submission(s).
Establishing Dossier Plans for the assigned submission types/projects considering inputs from functional area representatives and key stakeholders.
Maintaining effective interactions with relevant stakeholders and other RSMO colleagues as appropriate to ensure priority conflicts, resource issues and deviations from the plans are identified and resolved.
Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
Monitoring the effectiveness of appropriate submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality.
Meeting regularly with submission stakeholders to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
Interfacing with cross-functional representatives as appropriate to manage the dossier preparation process and ensure all aspects of the plan are coordinated and executed efficiently.
Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable.
Tracking submission events/activities in appropriate systems/tools.
PRINCIPAL RESPONSIBILITIES:
These responsibilities, including complexity and scope of submissions, may vary depending on role of employee and may include but are not limited to the following:
Manage preparation and/or publishing of submissions across the product lifespan in line with Regulatory strategy.
Partner across GRA and functional area contributing groups as needed for assigned projects.
Establish the Dossier Plan(s) for the life cycle submissions considering inputs from functional area representatives and key stakeholders.
Establish and maintain effective interactions with key partners as appropriate to ensure priority conflicts, resource issues and deviations from the plan are identified and resolved.
Ensure that all required documents are included in the dossier.
Track submission events/activities in appropriate systems/tools.
Liaise with RSMO staff as required.
Support development of departmental work practices, process enhancements/improvements, and associated training materials.
Monitor the effectiveness of the submission process and initiate changes within the scope of decision making authority to minimize inefficiencies and ensure/improve quality.
Represent RSMO function on Janssen initiatives where appropriate.
Develop/maintain associated process tools and relevant training documentation.
Support compliance needs as appropriate. May have following publishing activities as defined by the particular role or job function.
Determine the scope of the electronic publishing requirements for the dossier
Utilize current electronic document management and publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions with a high degree of independence
Provide component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (eg, bookmarking, linking, PDF version, etc.)
Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements
QC electronic and paper submissions to ensure compliance with company and applicable health agency requirements
Maintain openly, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission
Participate on special projects and process improvement initiatives, as needed
Cultivate ongoing effective relationships with publishing contributors across LSM and RA Therapeutic Areas
THE COMPANY
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges