Executive Director Regulatory Affairs
RemoteOK Company
Posted 3 hours ago • Via remoteOK.com
Description
Job Overview
- Role: Executive Director Regulatory Affairs
- Company: RemoteOK Company
- Location: Remote
- Salary: Competitive / Not Disclosed — confirm during interview
- Listing Source: Remote OK
Job Description
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine whatâs possible.
Title: Executive Director, Regulatory Affairs
Location: Remote (West Coast hours preferred)
Reports to: SVP, Chief Regulatory Officer
Position Overview
The Executive Director, Regulatory Affairs will provide strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.
The ideal candidate is a seasoned regulatory leader with deep experience in advanced therapies who can shape regulatory strategy from early development through approval and launch, while partnering closely with Clinical, CMC, Commercial, Market Access, and Legal teams.
The Executive Director will define and execute global regulatory strategy to support clinical development, registration, and commercialization of Kyverna's autoimmune cell therapies. The role requires the ability to translate scientific and clinical data into approvable, commercially viable labeling and to lead interactions with regulatory authorities, including FDA and global counterparts.
\nRegulatory Strategy & Leadership
- Lead global regulatory strategy for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management.
- Provide regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation.
- Anticipate and address regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up.
Health Authority Engagement & Negotiations
- Serve as the primary senior regulatory interface with FDA, EMA, and other global health authorities.
- Lead and/or support key regulatory meetings, including INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, Advisory Committees, and post-marketing commitments.
- Drive regulatory negotiation strategy, including benefit-risk, endpoints, comparability, and post-approval requirements.
Labeling Strategy & Commercial Readiness
- Own and drive labeling strategy from early development through approval, ensuring labels support commercial differentiation, patient access, and lifecycle value.
- Lead development of Target Product Profiles (TPPs) and ensure alignment across Clinical, Regulatory, Commercial, and Market Access.
- Partner with Commercial, Medical Affairs, and Market Access to ensure regulatory decisions support launch readiness, promotional strategy, and payer engagement.
- Lead label negotiations with health authorities, balancing scientific evidence, regulatory expectations, and commercial objectives.
Regulatory Submissions & Execution
- Oversee and contribute to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages, orphan drug applications, and other regulatory filings.
- Ensure submissions are high-quality, compliant, and strategically positioned.
- Maintain oversight of submission timelines, dependencies, and risk management, providing clear communication to senior leadership.
Cross-Functional & External Collaboration
- Act as a strategic partner to Clinical Development, CMC, Research, Commercial, Legal, BD, and Alliance Management teams.
- Provide regulatory due diligence and strategic input for business development, in-licensing, out-licensing, and partnership opportunities.
- Oversee regulatory activities performed by CROs, consultants, and partners, ensuring quality and strategic alignment.
Team Development & Operational Excellence
- Lead, mentor, and scale a high-performing regulatory team, fostering accountability, development, and a culture of collaboration.
- Establish and maintain regulatory policies, procedures, and infrastructure to support a growing, late-stage organization.
- Stay current on US and global regulatory intelligence and communicate key implications to stakeholders.
- Bachelor's degree in a scientific discipline required; advanced degree preferred.
- 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience.
- Cell and/or gene therapy experience preferred; autoimmune disease experience highly preferred.
- Demonstrated success leading global regulatory strategies through late-stage development and/or approvals, ideally including BLA/MAA experience.
- Proven experience with labeling strategy development and negotiation, with strong understanding of commercialization impacts.
- Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred.
- Track record of effective engagement with FDA OTP and/or divisions overseeing autoimmune or immune-mediated diseases.
- Strong executive communication skills with the ability to influence senior leadership and Board-facing audiences.
- Demonstrated ability to lead and scale teams in a fast-paced, high-growth environment. Prior supervisory experience preferred.
- Strategic mindset with the ability to balance scientific rigor, regulatory compliance, and commercial impact.
The national base salary range for this position is $270K-$300K annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data. This position is also eligible for bonus, benefits, and participation in the company's stock plan.
Salary & Compensation
The salary for this role is not publicly disclosed. Based on industry benchmarks, roles of this type in India or remote-first companies typically offer compensation in line with market rates for the experience level required. We recommend researching platforms like Glassdoor, Levels.fyi, or AmbitionBox to gauge expected ranges before your offer discussion.
In addition to base salary, many employers in this sector offer a comprehensive benefits package that may include:
- Annual or performance-based bonuses
- Health, dental, and vision insurance
- Provident Fund (PF) and Gratuity contributions (India)
- Paid Time Off (PTO), sick leave, and public holidays
- Professional development budget and learning allowances
- Stock options or Employee Stock Ownership Plans (ESOPs) at select companies
- Flexible or remote working allowances
- Parental leave and family health coverage
Note: The specific benefits offered by this employer should be confirmed during the offer stage. Not all benefits listed above may apply to every organisation or role type.
Work Arrangement
Type: Fully Remote
This role is designed for a fully remote work arrangement. You will have the flexibility to work from any location, provided you have a stable internet connection and can align with the team's core collaboration hours. The company supports remote employees with the necessary tools, virtual team-building activities, and regular check-ins to ensure productivity and a strong sense of belonging. Equipment and home-office stipends may be provided — check the job listing or confirm during the offer stage.
Typical Interview Process
While each organisation structures its hiring differently, candidates for this type of role typically go through the following stages:
- Resume and application screening
- Introductory phone or video call with HR
- Role-specific skill or competency interview
- Final interview with the hiring manager or panel
- Reference checks and offer discussion
Tip: Research the company's products, culture, and recent news thoroughly before each interview round.
About the Employer
RemoteOK Company is the organisation posting this opportunity. While full company details are available on the original job listing, here is what you should research before applying:
- Company size and culture: Review the company's LinkedIn profile, Glassdoor reviews, and their official website to understand team size, work culture, and employee satisfaction.
- Products and services: Familiarise yourself with what the company builds, sells, or delivers. Being knowledgeable about their offerings will set you apart during interviews.
- Recent news: Search for any recent fundraising, acquisitions, product launches, or leadership changes — these often come up in interviews and signal company health.
- Location and offices: The role is based in or around Remote. Confirm office address, remote policy details, and travel requirements during the process.
- Where this listing was found: This job was sourced from Remote OK.
How to Apply & Preparation Tips
To apply for the Executive Director Regulatory Affairs position, follow these steps:
- Tailor your resume: Customise your CV to match the specific requirements listed in the job description. Use keywords from the posting to pass Applicant Tracking System (ATS) filters.
- Write a compelling cover letter: Even if not mandatory, a concise cover letter demonstrating your enthusiasm and fit for the role significantly improves your chances.
- Apply via the original listing: Use the apply link on the original job post to submit your application. Avoid applying through third-party channels that may delay or lose your submission.
- Prepare for phone screening: Be ready for an initial call within 3–7 business days of applying. Have your resume and a quiet space ready.
- Follow up professionally: If you haven't heard back in 7–10 business days, a brief, polite follow-up email to the recruiter is acceptable and often appreciated.
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Disclaimer: This listing is aggregated from a public job board for informational purposes. JobSetuu does not guarantee the accuracy or current availability of this position. Always verify the details on the employer's official careers page before applying.
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