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Associate Director, Regulatory Affairs

Framingham (MA), US

About KalVista Pharmaceuticals, Inc. 

KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world.

For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.

 

ABOUT THE ROLE

The Associate Director, Regulatory Affairs will join the Regulatory Development team at KalVista in contributing to the development of regulatory submissions in alignment with company objectives and support the successful commercialization of KalVista’s products. The position provides regulatory expertise and guidance across both pre and post approval activities, serving as the regulatory lead for designated territories. Responsibilities include ensuring ongoing regulatory compliance within those territories while partnering cross-functionally to support strategic and operational regulatory requirements.

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

Impact/Influences:

  • Regulatory Affairs Department
  • Business development, Commercial, Medical Affairs, Pharmacovigilance, Supply Chain and Quality functions
  • Launch teams
  • Competent Authorities and Regulatory Agencies.
  • Consultants and Vendors

 

QUALIFICATIONS

  • 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

 

OUR VISION

We Deliver Novel Therapies That Empower People To Live Better Lives.

 

Our OPERATING PRINCIPLES, referenced below, guide our behaviors and decisions:

Define Success – And Then Deliver
Act with outcomes in mind. Have high expectations. Details Matter.

Be Data Driven And Openly Debate – But Be Decisive
Time is valuable. Say the thing you can’t say. Understand timelines and meet them.

Have An Ownership Mentality
This is your company; treat it that way. Protect our resources, reputation, and results.

Be Internally Collaborative And Externally Competitive
We go further, faster, together. Have a bias for action, but bring others along. Offer solutions, not just problems.

Good People = Great Company
Act with integrity. Assume positive intent. Be Kind.

 

Important Notice to Third-Party Recruiters & Staffing Agencies:

The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service.

If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.

Thank you for your understanding and cooperation.

Pay Range

$185,000 - $205,000 USD

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