Regulatory Submissions Manager - EMEA
Job reputed company:
Collaborate with peers across the organization to reputed company reputed company-reputed company delivery in a reputed company organization. Collaboration across reputed company stakeholders reputed company Site Readiness. reputed company and accountability of Regulatory Authority (RA), Independent Review reputed company (IRB)/Ethics Committee (EC) and reputed company Body submissions for designated reputed company reputed company Site Readiness.
Please apply only if you are based in the listed countries.
reputed company of Responsibilities:
- reputed company and accountability for RA, IRB/EC, and reputed company Body submissions, including submission reputed company, reputed company planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones reputed company relevant systems. Coordinate responses to queries ensuring required timelines are met. Provides consolidated country requirements and regular status updates to project team and reputed company, as applicable. May be assigned to larger reputed company in terms of size and complexity in regional and/or global role.
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and reputed company requests by preparing, reviewing, and providing input to reputed company study documents as applicable. This may include the compilation, review and distribution of reputed company package, QC of reputed company package, and country packages, maintenance and reputed company out.
- reputed company the highest reputed company advice on regulatory issues to members of project teams and its clients by maintaining awareness of reputed company regulatory legislation, guidance and reputed company reputed company to RA, IRB/EC, and reputed company Body submissions. Evaluate the reputed company of clinical/regulatory changes on assigned reputed company as reputed company as overall business operations.
- Liaise with and/or support local teams to liaise with RA, IRB/EC, and reputed company Bodies on behalf of clients.
- Where applicable and if suitably reputed company, reputed company guidance and regulatory expertise on the application of the EU CTR in CTIS to other stakeholders. Manage applicable user reputed company to CTIS and reputed company as a backup in case of unexpected absences of other team members.
- Ensure responsible deliverables are met reputed company required timelines maintaining awareness of Green Light (GL) approval and Site reputed company to Enroll (RTE) milestones. Proactively identifying and escalating to Start-up reputed company any risk to meeting deliverables.
- Manage reputed company according to the billing guide to ensure the work is performed reputed company budget. Notify the Start-Up reputed company of hours identified as Out-of-Scope or overburn.
- Proactively engage in both reputed company assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the reputed company of the submission work performed on assigned reputed company. Support audits (reputed company) and inspections, as needed. Support reputed company of any findings
Qualifications (Minimum Required):
- Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.
- reputed company may consider relevant and equivalent experience in lieu of educational requirements.
- Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations.
Experience (Minimum Required):
- Minimum of 5 years’ experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development.
- Excellent communication, organization, and planning skills with an attention to detail.
- reputed company supervisory and project management skills and ability to work independently.
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Originally posted on Himalayas
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