Planet Pharma
Regulatory Affairs Submission Management Associate
Planet Pharma, Florham Park, New Jersey, us, 07932
Regulatory Affairs Submission Management Associate
Join to apply for the
Regulatory Affairs Submission Management Associate
role at
Planet Pharma
Target PR Range: 28-38/hr
This associate manages low to medium impact submission projects involving multiple cross‑functional regulatory submission teams. They establish and maintain submission content planners and timelines, facilitate tactical submission team meetings, prepare content planners for publishing, interface with publishing vendors, and fulfill submission management functions on project teams to support development, marketing, and post‑marketing regulatory authority applications.
Responsibilities
Manages low‑to‑medium impact submission projects to ensure timely delivery of high‑quality dossiers that meet technical specifications defined by regulatory authorities.
Provides guidance and communication of established submission processes and standards to project teams.
Participates in submission team meetings and coordinates multiple concurrent interrelated activities for submission projects.
Coordinates submission publishing with offsite publishers, prepares content planner for publishing, and works with vendor to resolve publishing issues; may perform in‑house publishing tasks.
Facilitates creation or procurement of submission content deliverables such as cover letters and forms.
Performs detailed quality reviews of published output to ensure compliance with regulatory standards and health authority guidances.
Contributes to development of optimal business processes and standards to ensure high quality submissions.
Suggests process improvements, including changes to software and business processes.
Builds and maintains positive relationships internally and externally, influencing without direct authority.
Manages own projects under oversight, reviews progress with manager, and may assist with onboarding staff.
Qualifications
Bachelor’s degree.
Two years of pharmaceutical or industry‑related experience.
Preferred experience with publishing‑related software tools (Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat).
Higher education may compensate for years of experience and vice versa.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
Regulatory Affairs Submission Management Associate
role at
Planet Pharma
Target PR Range: 28-38/hr
This associate manages low to medium impact submission projects involving multiple cross‑functional regulatory submission teams. They establish and maintain submission content planners and timelines, facilitate tactical submission team meetings, prepare content planners for publishing, interface with publishing vendors, and fulfill submission management functions on project teams to support development, marketing, and post‑marketing regulatory authority applications.
Responsibilities
Manages low‑to‑medium impact submission projects to ensure timely delivery of high‑quality dossiers that meet technical specifications defined by regulatory authorities.
Provides guidance and communication of established submission processes and standards to project teams.
Participates in submission team meetings and coordinates multiple concurrent interrelated activities for submission projects.
Coordinates submission publishing with offsite publishers, prepares content planner for publishing, and works with vendor to resolve publishing issues; may perform in‑house publishing tasks.
Facilitates creation or procurement of submission content deliverables such as cover letters and forms.
Performs detailed quality reviews of published output to ensure compliance with regulatory standards and health authority guidances.
Contributes to development of optimal business processes and standards to ensure high quality submissions.
Suggests process improvements, including changes to software and business processes.
Builds and maintains positive relationships internally and externally, influencing without direct authority.
Manages own projects under oversight, reviews progress with manager, and may assist with onboarding staff.
Qualifications
Bachelor’s degree.
Two years of pharmaceutical or industry‑related experience.
Preferred experience with publishing‑related software tools (Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat).
Higher education may compensate for years of experience and vice versa.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr