Regulatory Affairs Consultant, Biologics
Regulatory Affairs Consultant, Biologics
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
- 79 yrs of experience of authoring compiling and submission of countryspecific submission files (MAA and postapproval changes) of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets. Contribute to 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.
- Good understanding of regulatory guidelines regulatory framework including regional trends for various types of applications and procedures. Working experience in Regulatory Information Management Systems like Veeva Vault.
- Execute and maintain submission delivery plans submission content plans and proactively provide status updates to designated stakeholders.
- Strong communications and collaboration skills. Ability to work independently.
Required Experience:
Contract
Employment Type
Full Time
