We are seeking an experienced and detail-oriented regulatory affairs professional to join our team as a Director of Regulatory Submissions. This critical role will oversee the planning, management, and execution of regulatory submissions, ensuring high-quality dossiers that meet global regulatory standards. Acting as a strategic partner and conduit between cross-functional teams, this individual will streamline submission processes and drive continuous improvement in tools, templates, and SOPs. With a focus on collaboration and excellence, this role is pivotal in ensuring timely, accurate submissions that align with organizational objectives and regulatory requirements

Reporting to our SVP of Regulatory Affairs, you will positively impact patients’ when you:

• Accountable for the planning, management, and execution of regulatory submissions including, but not limited to, IND, CTA, Amendments, and in particular, major submissions such as (s)NDA, MAA, variations, etc.
• Accountable for identifying all elements of Regulatory submissions to ensure dossiers are of high quality and meet Regulatory standards
• Communicate key submission requirements with Global Regulatory Leads to ensure these elements are also part of the Regulatory strategy considerations
• Accountable for ensuring all required documents of Regulatory submissions are planned and procured for timely submission
• Act as the conduit between external functions and Regulatory to ensure execution excellence of assigned submissions
• Support the Regulatory Strategy and Submission Team
• Partner with key stakeholders including, but not limited to, Program Management and Medical Writing to ensure a streamlined submission preparation process
• Lead the creation and maintenance of all submission process SOPs and Work Instructions
• Drive continuous improvement on all Regulatory submission planning and execution related tools and templates
• Perform QC on all major regulatory submissions before filing with the respective Regulatory Authority

• Bachelor degree in a life science concentration; a Postgraduate degree in Regulatory Affairs is preferred
• 10+ years of experience in Regulatory Affairs is required including oncology experience
• Extensive experience in major regulatory submissions and submission project management is critical
• Deep understanding of relevant regulatory guidance documents that pertain to regulatory submissions is equally important
• Excellent command of verbal and written English is required
• Ability to work with cross-functional teams and across multiple projects at once while balancing multiple and overlapping timelines is important
• Proficiency in the use of various software that are relevant for regulatory project management as well as submission preparation is important
• A good understanding of regulatory submission publishing is preferred

At Karyopharm, we live and demonstrate our ICARE values every day!

If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission.

Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.

What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
• Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
• Wellness Program with a monthly stipend. 
• Generous Flex Time Off program and Holidays – we encourage you to recharge and spend time with family and friends.
• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
• Cell phone allowance
• In the U.S., the salary range for this position is $205,000 to $220,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors
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