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.
Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
Liaise closely with cross-functional members with aligned product responsibilities.
Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable)
Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents
Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.
QualificationsMaster in Pharmacy or Science Post Graduate
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