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For Companies At a Glance
- Tasks: Lead international regulatory strategy and ensure compliance for life-changing therapies.
- Company: KalVista Pharmaceuticals, a global leader in rare disease treatments.
- Benefits: Competitive salary, contract role, and the chance to make a real impact.
- Why this job: Join a passionate team dedicated to improving lives through innovative therapies.
- Qualifications: 10+ years in Regulatory Affairs with strong communication and project management skills.
- Other info: Dynamic environment with opportunities for professional growth and collaboration.
The predicted salary is between 36000 - 60000 ÂŁ per year.
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.
About The Role
KalVista seeks a highly motivated and knowledgeable Associate Director, Regulatory Affairs to support the development and execution of our international regulatory strategy. Reporting to the Executive Director, Head of International Regulatory Affairs & Regulatory Operations, you will play a key role in ensuring regulatory compliance and contributing to the successful commercialization of KalVista’s products. As a regulatory leader for designated international territories, you will provide expert guidance on regulatory submissions; this role will contribute to the development of regulatory submissions in line with Company objectives and support the successful commercialization of KalVista’s products ex-USA ("international"). This role will also support both pre and post approval activities. Additionally, you will contribute to KalVista’s Regulatory Intelligence process while ensuring all activities align with corporate objectives and global compliance standards.
Responsibilities
- Support international MAA submission, approval and post approval activities, 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
- Work closely with other regulatory team members to draft/put in place appropriate processes (SOPs) to ensure ongoing maintenance/regulatory compliance of marketing authorizations in international markets
- Impact and influence key leaders and cross‑functional groups including Business Development, Commercial, Medical Affairs, Pharmacovigilance, Supply Chain and Quality, while also becoming a significant RA team leader
- Contribute to KalVista’s Regulatory Intelligence process
- Work in conjunction with launch teams, interact with competent authorities and regulatory agencies, and manage consultant and vendor relationships
- Maintain compliance with KalVista’s Quality Management System and work to industry standards of GxP
Qualifications
- Minimum of BSc in Chemistry, Pharmacy or a Biological Science
- Minimum of 10 years’ experience in Regulatory Affairs
- Experience of Centralized Marketing Authorization Applications
- Experience of post‑approval license maintenance activities
- Experience of preparing and submitting Marketing Authorizations in UK, Switzerland and other international markets desirable
- 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
Associate Director, Regulatory Affairs in Salisbury employer: KalVista Pharmaceuticals, Inc.
Contact Detail:
KalVista Pharmaceuticals, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Regulatory Affairs in Salisbury
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field and let them know you're on the hunt for the Associate Director role. A friendly chat can lead to insider info or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of international regulatory strategies. Be ready to discuss how your experience aligns with KalVista's mission and the specifics of their products, like EKTERLY.
✨Tip Number 3
Showcase your leadership skills! Think of examples where you've influenced cross-functional teams or led projects successfully. This will demonstrate your capability as a regulatory leader at KalVista.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the KalVista team.
We think you need these skills to ace Associate Director, Regulatory Affairs in Salisbury
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director, Regulatory Affairs role. Highlight your relevant experience in regulatory affairs and any specific achievements that align with KalVista's mission. We want to see how you can contribute to our team!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a perfect fit for KalVista. We love seeing genuine enthusiasm for what we do.
Showcase Your Communication Skills: Since outstanding communication is key for this role, make sure your application reflects your written communication skills. Keep it clear, concise, and professional. We appreciate well-structured applications that are easy to read!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way to ensure your application gets to us directly. Plus, it shows you're serious about joining the KalVista team. We can't wait to hear from you!
How to prepare for a job interview at KalVista Pharmaceuticals, Inc.
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in relation to international markets. Familiarise yourself with the specific regulations and guidelines that KalVista adheres to, particularly for marketing authorisations in the UK and Switzerland.
✨Showcase Your Team Spirit
As an Associate Director, you'll be working closely with various teams. Prepare examples of how you've successfully collaborated with cross-functional groups in the past. Highlight your ability to influence and lead within a team setting.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in real-world regulatory scenarios. Think about challenges you've faced in previous roles and how you navigated them, especially regarding post-approval activities and compliance.
✨Communicate Clearly and Confidently
Outstanding communication is key in this role. Practice articulating your thoughts clearly and concisely. Be ready to discuss complex regulatory concepts in a way that's easy to understand, as you'll need to share information with various stakeholders.
