The AD / Director is responsible for the development and implementation of regulatory strategies for specific projects, while serving as the regulatory lead on the respective program teams. He/she will also be the regulatory contact with relevant regulatory authorities, as appropriate.
As a Karyopharmer, reporting to Executive Director, Regulatory Affairs, you will positively impact patients’ lives by:
• Develop response and submission strategies to regulatory information requests in close collaboration with cross-functional team members
• Develop various briefing packages and regulatory applications (e.g. orphan, pediatrics, expedited review pathways, etc.) to the FDA and other global health authorities, as applicable
• Support submission teams to successful filing and approval of all types of submission packages including clinical trial submissions and marketing applications and supplements
• Complete documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
• Identify and assess regulatory risks for assigned projects or programs.
• Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
• Participate and contribute in Health Authority meetings.
• Mentor other Regulatory staff members.
• Four-Year degree required, Life/Health Sciences preferred, and a minimum 3 years’ pharmaceutical industry experience, 2 years’ regulatory experience.
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
• Experience in interfacing with relevant regulatory authorities.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements, including interpretation or regulations, guidelines, policy statements, etc.
At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $180 K–$230 K USD.
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.
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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.
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