Direct message the job poster from freyr solutions global talent acquisition manager | specializing in pharma/bio-tech/med and it | experienced in lifecycle recruitment across the americas and… about freyr freyr is a leading global regulatory solutions and services company, supporting large, mid, and small-sized global life sciences companies. with a mission to accelerate compliance and enable businesses to bring their products to market faster, freyr operates in a dynamic, innovative, and collaborative environment. our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries. at freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. join a company that values innovation, integrity, and the power of collaboration. job title: clinical content qc editor location: bogota, colombia (remote) job type: permanent job description comprehensive qc review of clinical sections of regulatory documents, including but not limited to, ibs, investigational new drug (ind) applications, new drug applications (ndas), biologic license applications (blas), clinical trial applications (ctas), marketing authorization applications (maas), briefing packages for regulatory agency meetings/advice, including verification of all references and source data, to achieve the highest quality from a technical, regulatory, and compliance perspective. verify internal consistency within a document and across related documents. comprehensive con...
Requirements: submissions publishing team works closely with various stakeholders to ensure the timely completion of submission assemblies that adhere to regulatory health authority guidelines for electronic/hard copy submissions. the incumbent will support global process; executing end - to - end submission assembly which includes submission publishing, quality control verification, finalization and dispatch to ha via gateway or cd/dvd/hard copy **responsibilities**: - work closely with submission managers to produce high quality submission assemblies(ectd/nees/paper format) utilizing submission - ready documents that adhere to internal and external electronic submission guidelines - ensure submission assemblies meet the level of technical integrity required for health authority validation tools - assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right - first - time submission assemblies - identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions - manage regional submissions and support global submissions as a publisher - manage and/or mentor junior team members - proactively communicate requirements and issues to be considered to the submission team, and contribute to achieving realistic timelines.**benefits**: health insurance, full - time condiciones del empleo jornada laboral:tiempo completo tipo de empleo:trabajo fijo salario:a convenir cantidad d...
Requirements: hs diploma or equivalent with 1 to 6 years of regulatory experience or preferred: bachelor's degree with 1- 2 years of regulatory publishing experience 1 - 3 years of regulatory affairs or any other areas in regulatory experience depending on education **responsibilities**: regulatory affairs, labelling, publishing, regulatory we have multiple openings with experience level 0 to 6 years **benefits**: health, insurance, full - time condiciones del empleo jornada laboral:tiempo completo tipo de empleo:trabajo fijo salario:a convenir cantidad de vacantes:24 requerimientos experiência mínima:1 año sexo:indistinto...
**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 **technical support specialist** **description**: - good hands-on working in technical support for a product development company. - educate the customer about the nuances of the support process and anticipate any obstacles and challenges. - good it skills and comfortable using itsm ticketing tools such as service now, remedy etc.. - attention to issue details and documenting the issue in ticketing tool with adequate information. -...
**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...
**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 **technical support specialist** **description**: - good hands-on working in technical support for a product development company. - educate the customer about the nuances of the support process and anticipate any obstacles and challenges. - good it skills and comfortable using itsm ticketing tools such as service now, remedy etc.. - attention to issue details and documenting the issue in ticketing tool with adequate information. -...
**job title: assistant manager/artwork coordinator** **job type: permanent/full-time** **job location: colombia - remote** **minimum education qualification**: bachelor’s/master’s in pharmacy/pharma or other associated scientific discipline **key responsibilities**: - own and drive the artwork initiation and approval processes for all new products, changes / updates to existing products of pharmaceuticals and medical devices products - plan and initiate the artwork requests on time, coordination with other internal stakeholders, managing the artwork review and approvals, including mockup and production workflows for pharmaceuticals, consumers, medical devices products. - responsible for initiating any artwork creation or change as a result of regulatory affairs (ra) procedure or any other country-initiated request for change of artwork or technical artwork changes based on the information provided by the technical. - acts as project owner of all workflow requests - can place workflow requests on "hold" or request cancellation when necessary. - responsible for providing regulatory content, information, and documentation. - ensures that all applicable fields in the component request details within ra responsibility are populated. **responsible for regulatory compliance, in particular**: - conformity with the marketing authorization. - consistency with the text approved by the competent agency, - selection of the correct style (layout or branding), in order to be compliant with agency approved layouts for all components. - consistency of all packaging co...
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