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Company

Karyopharm Therapeutics Inc. · 20 hours ago

Director, Regulatory Submissions Lead

United States

Full-time

Remote

Director/Executive

10+ years exp

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Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Accountable for the planning, management, and execution of regulatory submissions including, but not limited to, IND, CTA, Amendments, and in particular, major submissions such as (s)NDA, MAA, variations, etc.

Accountable for identifying all elements of Regulatory submissions to ensure dossiers are of high quality and meet Regulatory standards

Communicate key submission requirements with Global Regulatory Leads to ensure these elements are also part of the Regulatory strategy considerations

Accountable for ensuring all required documents of Regulatory submissions are planned and procured for timely submission

Act as the conduit between external functions and Regulatory to ensure execution excellence of assigned submissions

Support the Regulatory Strategy and Submission Team

Partner with key stakeholders including, but not limited to, Program Management and Medical Writing to ensure a streamlined submission preparation process

Lead the creation and maintenance of all submission process SOPs and Work Instructions

Drive continuous improvement on all Regulatory submission planning and execution related tools and templates

Perform QC on all major regulatory submissions before filing with the respective Regulatory Authority

Qualification

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Regulatory AffairsRegulatory SubmissionsProject ManagementOncology ExperienceRegulatory Guidance DocumentsEnglish ProficiencySoftware ProficiencySubmission PublishingSOP CreationCross-functional Collaboration

Required

Bachelor degree in a life science concentration

10+ years of experience in Regulatory Affairs including oncology experience

Extensive experience in major regulatory submissions and submission project management

Deep understanding of relevant regulatory guidance documents that pertain to regulatory submissions

Excellent command of verbal and written English

Ability to work with cross-functional teams and across multiple projects at once while balancing multiple and overlapping timelines

Proficiency in the use of various software that are relevant for regulatory project management as well as submission preparation

Preferred

Postgraduate degree in Regulatory Affairs

A good understanding of regulatory submission publishing

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)