Regulatory Affairs Submissions Associate

Kelly Scientific Resources

2020-10-12 20:17:56

Job location Princeton, New Jersey, United States

Job type: fulltime

Job industry: Government & Defence

Job description

Senior Associate- Regulatory Affairs Submissions Temporary to Hire Princeton, NJ 08540 Remote/Work from Home- will need to report to Princeton in the future Required Skills:

  • Regulatory Affairs experience as it pertains to clinical drug development.
  • Direct regulatory submissions experience compiling INDs or other US applications
  • Working directly with FDA and CRO experience.
  • Must have the experience with IND submissions
  • For applicants with IDE experience, must have background with amendments and orphan drug applications. BS degree in Life Sciences or equivalent

Preferred Skills:

  • Possess experience with Canadian applications submission NDS.

Job Responsibilities:

  • Prepare routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs and

NDAs/MAAs/CTDs). Take ownership for specific pieces of work and may be the lead for Regulatory Submissions for projects.

  • Review/summarize scientific/research documents in preparation for submission to Regulatory

Authorities. Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.

  • Interact with the Publishing group, Copy Center or equivalent as necessary for the production

of submissions. Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to assigned product/project areas.

  • Assure compliance with regulatory requirements in relation to assigned projects.
  • Participate in project development and regulatory strategy planning sessions. Will participate

independently in client meetings and will proactively liaise with clients on regulatory submission issues. Experience:

  • 3 years' experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development


  • Bachelor's Degree in Life Sciences or equivalent

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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