Senior Manager, Regulatory Affairs Labeling

Role Overview & Key Functions::

• Accountable for the execution of regulatory strategies including, but not limited to, compiling regulatory submissions such as IND, CTA, Amendments, and support major submissions such as (s)NDA, MAA, variations, etc.
• Lead the compilation of Agency interaction documents such as Meeting Requests and Meeting Packages
• Act as the conduit between external functions and Regulatory Operations to ensure execution excellence of assigned submissions
• Lead Labeling Working Group for assigned submissions and responsible for USPI annotations and mockups
• Lead Regulatory initiatives including Regulatory Intelligence and Regulatory Science projects, compliance activities, and assigned tasks
• Maintain Regulatory Strategy Documents for assigned programs
• Co-chair Regulatory Subteam with the Global Regulatory Lead
• Accountable for submissions such as Annual Reports and Renewals for assigned products

• Bachelor’s degree in a life science concentration
• 5+ years of experience and preferrably with a Regulatory Affairs Postgraduate degree
• Good understanding of legislations, regulations, and policies that govern drug approvals and commercialization in the US, and preferably also in the EU
• Good understanding of relevant regulatory guidance documents that pertain to drug development and commercialization
• Experience with Regulatory Labeling such as leading Labeling Working Group and knowledge of USPI annotations and mock-ups
• Great understanding of Regulatory Intelligence tools and resources
• Excellent command of verbal and written English
• Ability to work with cross-functional teams and different project leads
• Proficient in the use of Microsoft Office, Adobe Acrobat, and SharePoint software.
• Ability to work on several projects at once while balancing multiple and overlapping timelines
• Careful attention to detail and accuracy

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