Senior Manager, Regulatory Affairs

4 days ago

Apply Now

Receive Emails with Similar Jobs

Karyopharm Therapeutics Inc.

WebsiteLinkedInAll Job Openings

Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company dedicated to pioneering novel cancer therapies. Driven by a belief in the extraordinary strength and courage of cancer patients, the company focuses on scientific innovation to develop potentially life-changing treatments for cancers with high unmet medical needs. Karyopharm is at the forefront of Selective Inhibitor of Nuclear Export (SINE) technology, addressing fundamental mechanisms of oncogenesis through ongoing clinical trials for various types of tumors, including hematologic malignancies and solid tumors.

oncology • pharmaceutical • biotech • multiplemyeloma • lymphoma

201 - 500 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Join our team as a Regulatory Affairs Manager. • Lead critical regulatory submissions and agency interactions. • Ensure compliance with evolving regulatory standards. • Manage labeling initiatives and regulatory intelligence projects. • Co-chair cross-functional subteams. • Accountable for execution of regulatory strategies. • Lead Labeling Working Group and maintain Regulatory Strategy Documents.

🎯 Requirements

• Bachelor’s degree in a life science concentration. • Postgraduate degree in Regulatory Affairs preferred. • 5+ years of related experience including experience with (s)NDA or (s)BLA submissions required. • Good understanding of legislations, regulations, and policies governing drug approvals in the US and preferably in the EU. • Understanding of regulatory guidance documents pertaining to drug development and commercialization. • Experience with Regulatory Labeling. • Excellent command of verbal and written English. • Ability to work with cross-functional teams. • Proficiency in Microsoft Office, Adobe Acrobat, and SharePoint. • Attention to detail and accuracy.

🏖️ Benefits

• Comprehensive and generous benefits package active on day one. • Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards). • Best in class medical (deductible paid by KPTI), dental, vision, disability, and life insurance. • Parental leave and a matching 401k program (immediate vesting). • Wellness Program with a monthly stipend. • Generous Flex Time Off program and Holidays. • Ample opportunities to learn and take on new responsibilities. • Cell phone allowance.