Regulatory Affairs Associate - Florham Park
1 month ago
Job summary
The Associate, Regulatory Affairs Submission Management manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.This individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing,
and post-marketing regulatory authority applications.
Responsibilities
- Manages low to medium impact (with respect to internal visibility risk complexity criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities.
- Acts as RA Submissions support project teams providing guidance communication established submission processes standards Provides input project publishing timelines deliverables Participates in team meetings Expedites coordinates multiple concurrent interrelated activities for submissions within required times Anticipates obstacles proposes solutions within team Coordinates publication offsite publishers/provides notification ensures all resources available meet deadlines Prepares planner notifying works resolve issues Performs detailed quality reviews published output ensure compliance Regulatory Standards Health Authority guidances including verification bookmarks hypertext links tables content moderately complex submissions Facilitates seamless integration business continuity efforts Contributes development optimal business processes department achieve customer satisfaction high-quality submissions Suggests implements process improvements software changes participate internal teams update documentation Demonstrates ability influence without direct authority Builds maintains positive relationships internally externally Supervision responsible managing own projects oversight Reviews progress manager regular basis direction provided manager May assist onboarding staff position accountability scope Receives assignments manager responsibility submitting overseeing ensuring completion following guidelines
Job description
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