Accountable for the oversight and deliverables of all ex-US and ex-Canada Clinical Trial Applications (CTA) for Karyopharm’s development programs. This candidate will be an active member of the respective Study Teams and will ensure cross-functional alignment and on-time / right-first-time submission and approval of CTA filings.

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

• Plan, execute and oversee all ex-US/ex-Canada CTA submissions in alignment with the respective program strategies and study team timelines
• Work hand-in-hand with internal Regulatory team to ensure execution excellence of all CTAs
• Oversee and manage all CRO contributions to Karyopharm’s CTAs and escalate critical issues as needed
• Ensure work orders and contracts of CROs are current to support all of Karyopharm’s CTA deliverables
• Develop regulatory strategies and author drafts of various documents intended for submission to global health authorities and Ethics Committees pertaining to CTAs
• Lead internal and external stakeholders to respond to Competent Authority information requests pertaining to the CTAs in an expeditious and high quality manner
• Be the internal expert of the EU Clinical Trial Directive/Regulation including regulatory submission requirements, as well as IVDR clinical submissions
• Assess change controls that pertain to CTAs and define regulatory requirements and perform risk assessments, as needed
• Act as the contact for ex-US/ex-Canada regulatory agencies relevant to assigned CTAs, where applicable
• Prepare and deliver effective presentations for external and internal stakeholders on all relevant CTA activities

• Bachelors Degree in the life sciences, graduate degree or certification in EU Regulatory Affairs preferred
• Minimum of 8 years of working experience along with a min of 5 years of regulatory experience which included hands-on work in EU CTAs
• Hands-on experience with filing CTAs under the EU Clinical Trial Regulation is a must
• Oncology experience is preferred
• Working knowledge of GCP and ICH requirements pertaining to clinical trials is a definite asset
• Strong organizational and project management skills is important
• Demonstrated written and verbal communication skills
• Experience working in a multi-cultural and matrix environment
• Experience working with and managing CROs

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), teamembers 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 PTO 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