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Regulatory Affairs Consultant / Project Manager - US Agent

USA - Any Region - Home Based Date posted 09/26/2021 Job ID 71128BR

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

Parexel currently has an excellent opportunity for a Regulatory Affairs Consultant / Project Manager with previous experience managing small/mid-sized projects at the IND/NDA/BLA maintenance stage coupled with previous experience representing clients as a US Agent.

This Home-Based position is part of our growing Regulatory Consulting Services Team and offers an amazing opportunity to join an industry leader in a field that continues to see tremendous growth and opportunity!

As a Regulatory Affairs Consultant / Project Manager you will:
  • Coordinate multi-disciplinary project teams and manage the day-to-day operations of domestic and international Regulatory projects
  • Strive to achieve operational excellence through on time delivery of projects that are within budget and to the highest quality with the goal to exceed client expectations
  • Provide guidance on FDA requirements
  • Interact with the FDA on behalf of clients for regulatory matters
  • Remain aware of relevant FDA regulations and apply such knowledge/guidance to projects
  • Serve as a designated Regulatory Contact or US Agent for clients which may include:
    • Assisting FDA in communications with the foreign company who wishes to market pharmaceutical products or medical devices in the US,
    • Responding to questions concerning the foreign establishment's products or devices that are imported or offered for import into the United States,
    • Assisting FDA in scheduling inspections of the foreign establishment and
    • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Qualifications

Successful candidates will have:
  • At minimum, possess an undergraduate degree in a clinical or health related field, advanced degree preferred
  • Previous Regulatory Affairs related experience in a Life-Sciences Consulting Firm, a Biotech or Pharmaceutical company, or experience as a Project Manager at the FDA or other Health Authority
  • 3-5 years previous experience managing cross-functional Regulatory projects to include previous experience managing the preparation, organization, and submission of FDA regulatory applications ie. INDs, BLAs, NDAs & all regulatory documents/submissions critical to product life cycle.
  • Knowledge of FDA processes and regulations​​​​​​​
  • Experience in communicating (verbal/written) with the FDA
  • Global regulatory experience is a plus

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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