Senior Regulatory Affairs Associate
Job Description
A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. A Senior Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. A Senior Associate may act in a client facing role with support from line management. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations.
EU Single/Workshare/Supergrouped Variation for CP and MRP (N&R and Established products) and HAQ support
Coordination of kick-off meeting and any other meeting and follow-ups
Reg Vault: creation of RO & SO and Submission content plan
Drafting of Cover Letter, Application forms
Navigating PLM portal for EU Application form Generation
Stakeholder Management
Finalization of submission content plans
Publishing request and QC of publishing output
Managing HA correspondences in Reg Vault
Shift: 12 pm to 9 pm IST
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