Director/Senior Director Regulatory Affairs - Oklahoma City, United States - ScientaSearch Limited

Description

A clinical-stage biotech focused on Rare Diseases. This company utilizes antibodies to harness the bodies immune system to fight off disease.
The Role

This person ill serve as the GRL for the company's early stage proprietary pipeline as well as supporting partnered programs with large pharma , reporting into the SVP of Regulatory Affairs.

Main Responsibilities
To provide regulatory leadership and support to cross functional development project teams to jointly achieve strategic objectives.
To be responsible for the US and ex-US regulatory activities associated with the project teams.
Develop regulatory scientific, and tactical strategic plans, and target labelling to support product development of products.

Provide leadership for the development and writing of regulatory submission documents, including Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.

Requirements
MD / PharmD / PhD Life science degree preferred
8+ years Regulatory Affairs Strategy (In Industry) experience
Scientific of clinical expertise in Auto-Immune Disease
IND, BLA Experience
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