Job Details

Requisition Number 15-0104
Post Date 7/31/2017
Company Akcea
Title Regulatory Affairs Associate
Employment Type Full Time
Description

Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.

Established as a subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics. In July 2017, Akcea closed its initial public offering of common stock and is listed on the NASDAQ Global Select Market under the symbol “AKCA.”

 

In the third quarter of 2017, we plan to file a marketing authorization for volanesorsen to treat patients with FCS and are seeking talented professionals to support our efforts.

Regulatory Affairs Associate

Reporting to the Senior Director, Regulatory Affairs, the Regulatory Affairs Associate will assist the Regulatory Department to provide expertise in translating clinical and nonclinical regulatory requirements into practical strategic regulatory plans. With supervision, the Regulatory Affairs Associate will help to author, compile, review and submit high-quality regulatory submissions to the FDA and other Health Authorities within company timelines and in accordance with regulatory guidelines and applicable federal laws. Under supervision, coordinates and writes clear, concise and accurate responses to inquiries from FDA and other Health Authorities resulting from their review of the submissions.  Submissions will include:  INDs, Amendments, Annual Reports, Orphan Drug Submissions, Meeting briefing packages and other correspondences.  The Regulatory Affairs Associate will work on projects and helps to solve problems where analysis of the situation or data requires evaluation and sound-interpretation of regulatory requirements and/or guidelines.

Responsibilities:

  • Interacts effectively with functional departments to coordinate/facilitate procurement of documentation required for submissions, ensuring that corporate timelines are met
  • Reviews documents for accuracy and with supervision, determines acceptability for use in new INDs, NDAs, Amendments, Annual Reports and other required FDA filings in order to ensure high-quality submissions and expeditious approvals from FDA
  • Helps to compile high-quality, original new INDs, NDAs, Amendments, and Annual Reports, Orphan Drug Applications
  • Helps department to stay current on changing regulatory guidelines and applicable federal laws and their impact
  • Works with Regulatory Operations to track submissions and Regulatory Commitments as well as archiving documents
  • Other duties as assigned

Requirements:

  • Bachelor’s Degree preferred
  • 1-2 years of Regulatory Affairs or pharmaceutical industry experience
  • 8-10 years pharmaceutical industry experience
  • Demonstrates knowledge and understanding of US and ex-US guidelines
  • Energetic, self-motivated and a hands-on professional with a strong work ethic
  • Strong critical and logical thinker with ability to analyze problems and recommend solutions
  • Ability to be a true team player working toward common goals
  • Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
  • Effectively prioritizes competing tasks in a fast-paced and dynamic environment

 

Excellent salary and benefits package offered.

For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com Reference #15-0104

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Akcea Therapeutics, Inc. is proud to be an EEO employer.

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