Be an early applicantLess than 25 applicants

Company

Karyopharm Therapeutics Inc. · 21 hours ago

Senior Manager, Regulatory Affairs Labeling

United States

Full-time

Remote

Senior Level

5+ years exp

Maximize your interview chances

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Insider Connection @Karyopharm Therapeutics Inc.

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsRegulatory SubmissionsRegulatory LabelingRegulatory IntelligenceLife Science DegreeRegulatory Guidance DocumentsMicrosoft OfficeAdobe AcrobatSharePointEnglish ProficiencyCross-functional Collaboration

Required

Bachelor’s degree in a life science concentration

5+ years of experience

Good understanding of legislations, regulations, and policies that govern drug approvals and commercialization in the US

Good understanding of relevant regulatory guidance documents that pertain to drug development and commercialization

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

Preferred

Regulatory Affairs Postgraduate degree

Good understanding of legislations, regulations, and policies that govern drug approvals and commercialization in the EU

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

Company

Karyopharm Therapeutics Inc.

Founded in 2008

Newton, Massachusetts, USA

201-500 employees

http://www.karyopharm.com

H1B Sponsorship

Karyopharm Therapeutics Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (7)

2022 (6)

2021 (7)

2020 (15)