Sr. Manager/Associate Director, Logistics & Trade Compliance at KalVista Pharmaceuticals

Framingham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Jan, 26

Salary

0.0

Posted On

03 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Logistics, Trade Compliance, Supply Chain, Import/Export, Drug Substance, Drug Product, Regulatory Knowledge, Problem Solving, Communication, Decision Making, Negotiation, Quality Assurance, Safety, Environmental Sustainability, Asset Utilization, Strategic Planning

Industry

Biotechnology Research

Description

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 EKTERLY® (sebetralstat) EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom and Switzerland for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information visit EKTERLY.com. About the role: KalVista seeks an experienced professional to support the Logistics & Trade Compliance function. In this role you will have responsibility for managing day-to-day logistics and have oversight of KalVista’s Trade Compliance within the Global Supply Chain organization. You will report to the VP, Global Supply Chain. This is an excellent opportunity to evolve this function to support the upcoming launches and advance the overall Supply Chain capabilities to deliver therapies that transform the lives of patients. Responsibilities: Build and manage logistics operations for optimal quality, safety, environmental sustainability, cost-effectiveness, and asset utilization Lead the logistics operations in a global, harmonized manner with execution in a decentralized way Ensure all company’s logistics operations are conducted in compliance with US and foreign trade laws. Lead/primary representative in customs audits, inspections, and regulatory agency inquiries Partner closely with Tax, Finance, Manufacturing to provide strategic and operational input into supply chain decisions Investigate and develop strategy and response to ensure compliance in accordance with appropriate laws and regulations Develop policies, SOPs, and Work instructions relevant to Logistics & Trade Compliance Qualifications: Minimum of 5 years’ experience within logistics, Distribution (GDP), and supply chain in the pharmaceutical industry and in a virtual manufacturing/supply environment Minimum educational requirement is a BS or a BA Experience with Import/Export of Drug Substance & Drug Product Experience with product HTC classifications, valuation, and Country of Origin determinations Global operations experience, import / export operations, working knowledge of regulatory, drug licensing, and operating requirements in a global market Hands-on experience in Logistics, trade compliance Effective communication, presentation, decision making, influencing and negotiation skills Extensive acumen in problem solving, managing priorities and commitment to quality & safety All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. 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.

Responsibilities

Manage day-to-day logistics and oversee trade compliance within the Global Supply Chain organization. Develop policies and strategies to ensure compliance with US and foreign trade laws while optimizing logistics operations.