Regulatory Affairs Senior Associate Health
Full-time
Parexel
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. Around 4-7 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (small molecules as well as biologicals including Vaccines monoclonal antibodies) in various markets mainly US and EU.
Good understanding of regulatory framework including regional trends for various types of applications and procedures.
Lead and / or contribute to the planning preparation authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
Experience in handling CMC related health authority queries and author responses to HA requests
Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND IMPD DMF BLA NDA and MAA applications.
Identify quality and/or timeliness issues with source documents as early as possible.
Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
Authoring content of the drug product label (EU Canada AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
Artwork management for countries with label in English.
Required Experience:
Vacancy posted a month ago
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