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KalVista Pharmaceuticals, Inc. · 1 day ago

Associate Director, Regulatory Affairs

Framingham, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$185K/yr - $205K/yr

10+ years exp

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases. The Associate Director, Regulatory Affairs will contribute to the development of regulatory submissions and ensure ongoing regulatory compliance while collaborating cross-functionally to support strategic and operational requirements.

BiotechnologyDiabetesHealth Care

Responsibilities

Support IND/NDA/MAA preparation, submissions, assessment and post approval activities in designated territories, in close collaboration with the Global Regulatory Lead

Represent regulatory affairs in allocated launch teams as required

Provide regulatory support to business development, commercial, market access, pharmacovigilance, supply chain and quality functions

Working closely with other regulatory team members, to draft/put in place appropriate processes (SOPs) to ensure ongoing maintenance/regulatory compliance of marketing authorizations in designated markets

Contribute to KalVista’s Regulatory Intelligence process

Maintain compliance with KalVista’s Quality Management System and work to industry standards of GxP

Qualification

Regulatory Affairs experienceFDA submissionsSOP developmentChemistry degreePharmacy degreeBiological Science degreeCommunication skillsProject managementTeam player

Required

Minimum of Degree in Chemistry, Pharmacy or a Biological Science

Minimum of 10 years' experience in Regulatory Affairs

Experience of FDA, Health Canada and LATAM regulatory submissions

Experience of post approval maintenance activities

Experience in developing and writing SOPs/Work Instructions for post commercial regulatory compliance processes

Outstanding communication (written and verbal) skills and willingness to share information

Ability to plan and execute projects to tight deadlines

An excellent team player with a proven ability to manage projects as part of an interdisciplinary team

Company

KalVista Pharmaceuticals, Inc.

For nearly a decade, KalVista Pharmaceuticals has been focused on addressing the critical unmet needs of those living with hereditary angioedema (HAE).

Founded in 2011

Cambridge, Massachusetts, USA

51-200 employees