As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
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"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"Riley – Regulatory Affairs Consultant
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Work with industry leaders and subject matter experts.
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Opportunities to work on multiple accounts – never boring!
Strong management with depth of experience working for global health authorities.
We are currently looking for a client dedicated Regulatory Affairs Program Manager - WHO .
In this role you will be responsible for RA System Implementation activities and Support WHO regulatory activities (Preparation and submission activities; Planning and tracking activities, Mapping; Archiving information; Following KPI and taking related action; Investigation and solving issue; Support on regulatory exception vaccine supply management; Support on WHO project; Drafting requested document; Leading meeting and sharing meeting minutes). You may also act as a RA contact database management support.
This role can be based in Poland, Romania, Hungary, Croatia or Lithuania - office or home based.
Upload in CARS / Vault communication traceability with WHO & UN agencies
Upload in easydoc of REVS (exception form for supply)
Update OPAL requests (adding submission date & approval)
Specific subjects Investigation (e.g. investigation on sharing platform)
Management support for RA database
Support to draft communication emails and PPTs
Will be involved more in the processes with WHO (formalize the annual report)
Supporting and handling WHO specific submissions and routine requests
Keeping working instructions up-to-date
Monitoring the planning and timelines
Skills and Experience required for the role:
Good understanding of pharmaceutical business, drug development, and project management
3-5 years of experience in Regulatory Affairs
Data management and planning experience
Excellent administrative skills, attention to detail
Fluent in English
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