**experience 5 - 8 years** **description** - 1. independently manages submissions (and supports internal rpm in managing initial major global filings). - 2. co-leads swgs with the designated regulatory lead for non-major global markets maas and supplements - 3. work with functional sub-teams to develop timeline based on data availability and other critical path activities. identify critical path to submission. maintain timeline during project lifecycle. - 4. schedule kick off meeting. - 5. ensure appropriate representation from needed cross-functional team members. - 6. create draft agenda with grl/emrl or reg lead and work with cross-functional team to gather presentations. provide agenda for kick off prior to meeting. - 7. facilitate kick off. represent project management at kick off (i.e., present timelines, swg overview, other slides as needed). - 8. send call for agenda prior to meeting. collect agenda topics from team members and prepare draft agenda for review with grl/reg lead. collect team member presentations for meeting. send agenda to team at least 1 day prior to meeting. - 9. keep team on track and hold team members accountable to represent function. - 10. send meeting minutes to team for input and save final minutes to interact - 11. record and track action items. record decisions made and document in decision log for major decisions. record risks raised by team members in risk log, escalate to grt for major risks. - 12. create and maintain submission timeline in project plan. confirm rpp is updated as necessary. identify and raise potential reso...
Should have knowledge/experience with labelling software - should knowledge on **regulatory labeling.**: - should be familiar with global labelling requirements & standards - good communication skills, able to do multi-tasking - should follow-stringent processes & identify and suggest improvements in processes **experience**: - labelling: 1 year (required) - regulatory: 1 year (required)...
Should have knowledge/experience with submission software, **lorenz docubridge**: - should knowledge on **ectd publishing.**: - should be familiar with global ectd requirements & standards - good communication skills, able to do multi-tasking - should follow-stringent processes & identify and suggest improvements in processes **experience**: - ectd: 3 years (required) - publishing: 3 years (required)...
**senior rims associate - remote opportunity with freyr inc** **about freyr inc**: freyr has grown to be a trusted regulatory partner to 1100+ global customers, including 8 of the global top 10 drugs and biotechnology companies, 4 of the top 10 med tech and healthcare equipment and services companies, 2 of the global leading covid vaccine companies, 5 of the global top 10 household & personal products companies, and 2 of the top 10 food & drinks companies, and 100s of mid-market $1+ billion biopharma, and several small and medium, fast growing life sciences companies, cros, and standards agencies. **our specialties**: regulatory consulting & strategy, regulatory operations & affairs, regulatory software solutions, regulatory information & intelligence, global regulatory responsibility services, regulatory publishing & submission, regulatory medical writing, idmp, medical devices regulatory services, regulatory artwork & labeling, cmc, medical devices, pharmaceutical, biotechnology, biosimilar, cosmetics, consumer healthcare, otc, regulatory intelligence, food supplements, global regulatory affairs, labeling, artwork, chemicals, ectd, and regulatory software solutions **what you will be doing as a senior rims associate**: - archival of regulatory notifications, agency approved, clean labeling, 1572's/cv' and regulatory correspondence to and from the health authority. - file search and retrieval - create or update transactional rim data: applications, events, activities, regulatory objectives, submissions, registrations, and associated details. - generate wwma (w...
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