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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Regulatory Affairs Consultant- Clinical/Nonclinical Regulatory Writing

Job ID 77610BR USA - Any Region - Home Based
AMAZING HOME-BASED OPPORTUNITY TO GROW PROFESSIONALLY! THIS ROLE OFFERS UNPARALLELED CROSS FUNCTIONAL REGULATORY AFFAIRS, THERAPEUTIC AREA, AND FDA EXPOSURE!

If you love writing, have a passion for Regulatory Affairs, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining tremendous professional experience, then Parexel's Regulatory Consulting team has an amazing opportunity for you!

Our Regulatory Consulting Team is expanding, and we are seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant to join our team of Regulatory experts and assist our clients with pre-market and post -market submissions! This is a great opportunity to continue to expand your Regulatory Affairs experience as you work alongside and are mentored by some of the Industry's leading experts. As a member of the Regulatory Consulting team, you will gain incredible experience as you prepare for client and FDA meetings, write various sections of Applications, interact with Industry Thought Leaders and Subject Matter Experts, and so much more!

In this role, you will:
•Serve in the capacity of Regulatory clinical technical writer and as US Agent and as a Regulatory Generalist
•Prepare regulatory submissions to FDA across a diverse portfolio of product types (small molecule, biologics, combinations), development phases, and scientific disciplines (nonclinical, clinical, general regulatory and/or device).
  • Authoring of Clinical Overviews (CTD Module 2.5) and Clinical Summaries (CTD Module 2.7)
  • Preparing CTD modules 4 and 5
  • Authoring clinical sections of regulatory documentations (IMPDs, Scientific Advice Briefing Documents, Investigator Brochures, Pediatric Investigation Plans, Orphan Designation Applications, etc).
  • Non-Clinical Authoring:
    • pIND – MRL, BD
    • IND – IB, Modules 2.4, 2.6.1, 2.6.2, 2.6.3, 2.6.4, 2.6.5, 2.6.6, 2.6.7, 4
    • NDA
    • BLA
    • CDP
    • SPA
•Support multi-functional projects as project manager and collaborate with technical leads and clients to perform the work
•Review documents to provide quality assurance for both pre- and post-approval regulatory document submissions.
•Produce first-time quality work to meet expectations of both project lead and clients.
•Foster a strong network of colleagues through continued interactions during project engagement

Qualifications

  • PhD with 3+ yrs industry-related or academic focused regulatory affairs experience OR MS/BS in a scientific discipline and 3-10yrs regulatory affairs experience (past relevant regulatory affairs experience will determine level)
  • Ability to summarize regulatory guidelines and apply them appropriately
  • Ability to understand and interpret clinical/non-clinical data from different sources
  • Experience authoring regulatory documents FDA submissions (i.e. meeting materials and IND/NDA/ or BLA documents) or writing in peer reviewed journals
  • Experience with safety reports (DSUR, PSUR) is a plus
  • Project management and consultant experience necessary
  • Previous US Agent/liaison experience with health authorities is highly valued, but not required
  • Excellent interpersonal and intercultural communication skills, both written and verbal required

    This role may require <30% domestic and/or international travel in the future

    Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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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