About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). The company disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the U.K., Europe and Japan later in 2024.
KalVista has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization. Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, U.K.; Zug, Switzerland; Tokyo, Japan and Salt Lake City, UT.
About The Role
The Manager/Sr. Manager, Regulatory Affairs, CMC is responsible for the Module 3 part of the eCTD documentation to ensure compliance with global marketing authorisations and global clinical trial applications. This position is accountable to maintain Module 3 of the eCTD documentation and IMPD documents, ensuring regulatory compliance at all times. You will serve as the primary contact, provide regulatory input to all CMC change controls including regulatory categorisation of the change and update(s) to relevant Module 3/CMC documentation.
Responsibilities
* Responsible for regulatory input to all CMC change controls and assess the impact of changes on the global regulatory Module 3/IMPD documentation
* Prepare plans for, and lead the preparation/update of, CMC documentation to support clinical trial applications including: IMPD, IND Module 3, and Module 3 of New Drug Applications/Approved Drug Products
* Ensure change actions are raised to track regulatory approvals and update CMC documentation
* Be responsible for maintaining up-to-date, controlled versions of all regulatory Module 3/IMPD documentation and tracking the versions submitted to each competent authority, where necessary
* Ensure that all CMC updates are reviewed, QC checked and approved in accordance with KalVista procedures in a timely manner to support regulatory submissions
* Provide input into Regulatory CMC risks assessment and mitigation plans
* Support the regulatory authority submissions of CMC updates
* Manage responses to Competent Authorities on any CMC related issues
* Escalate issues that may affect registration, regulatory compliance and continued lifecycle management of the product
* Maintain compliance with KalVista’s Quality System and work to industry standards of GxP
* In conjunction with QA team, prepare for and support regulatory agency inspections.
* Maintain current knowledge of relevant legislation in the UK, EU, USA and all relevant global guidelines (including ICH)
Requirements
* BSc or PhD in Pharmacy, or Chemistry
* 5 years of working in pharmaceutical drug development with minimum of 2 years regulatory affairs experience
* Knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications
* Up to date knowledge on the relevant regulations and guidelines for FDA, EU, MHRA and ICH
* Able to write/review/compile CMC sections of Module 3 and IMPD with minimum supervision
* Outstanding interpersonal and communication (written and verbal) skills
* Ability to manage multiple tasks with effective planning and coordination
* Ability to work to tight deadlines
* Highly organised with excellent attention to detail
* A problem solver capable of identifying issues and implementing solutions
* An excellent team player with a proven ability to manage projects as part of an interdisciplinary team
* Proficient at using Microsoft Office software (particularly Word and Excel)
#J-18808-Ljbffr