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Manager of Regulatory Affairs

Insight Recruitment Lincoln, NE

Job Description

We are a global leader in the design, manufacture, and sale of innovative products for customers in the life science and biotechnology industry and are entering a new phase of growth with products designed to improve surgical outcomes in humans.   We are looking for an experienced Regulatory Affairs Manager to provide technical expertise and lead this exciting chapter of our company’s growth. 

In this highly visible, key role you will provide strategic and operational leadership on global clinical regulatory activities with a focus on regulatory filings.  The successful candidate must have pre-clinical and early phase human clinical trial experience, including clinical safety experience with successful IND and NDA submission experience.

We offer a very competitive salary, excellent benefits and the opportunity to lead a brand-new and growing team within our company!

Job Responsibilities 

  • Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of clinical submissions required for regulatory approval.
  • Respond to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
  • Review detailed scientific information and assess whether technical justifications are presented clearly and conclusions are adequately supported by data.
  • Effectively plan, organize, and conduct meetings in close collaboration with leads from other functional areas. Assure compliance with project team timelines and milestones.
  • Interface with functional areas (Clinical, Nonclinical, Commercial) to identify and obtain information required for regulatory submissions.
  • Prepare FDA application with project teams including INDs and NDAs.
  • Serve as primary liaison for FDA communications regarding filings.
  • Provide interpretation of regulatory authorities’ feedback, policies and guidelines to product teams.
  • Lead international product registration and interpret regulatory rules as they relate to company product and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures.
  • Procure and oversee outside vendors and Regulatory Consultants as required.
  • Provide organizational support and be prepared to manage personnel as company grows its product development pipeline.

Requirements (flexibility with some of these)

  • Bachelor’s degree in a Life Sciences discipline or equivalent.
  • Must have at least 5 years of pharmaceutical experience, and at least 5 years of hands-on regulatory affairs and successful IND and NDA submission experience.
  • Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills.

The right candidate can utilize their expertise and make this role their own.  It is a great time to join our growing firm!

Job Details

Date Posted October 13, 2017
Date Closes November 12, 2017
Located In Lincoln, NE
Job Type Full-time Employee
Compensation Salary, Based on Experience
Experience Level Intermediate (3-7 yrs. experience)
Hours 45 hours per week
Start Date Immediately
Positions Available 1
SOC Category 19-1042.00 Medical Scientists, Except Epidemiologists
Zipcode 68516
Name Shawn Mischnick
City, State and Zip Lincoln, NE 68516
Phone 402-730-2645

This job offers the following benefits

  • 401(k) Retirement Savings Plan
  • Dental
  • Medical

This job requires the following skills

  • Regulatory Compliance
  • Manufacturing - Management
  • GMP
  • Other - Planning
  • Other - Project Management
At a Glance
Enjoy these benefits
  • 401(k) Retirement Savings Plan
  • Dental
  • Medical