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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Tap Growth aiPhiladelphia, Pennsylvania, US
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🌟 We're Hiring : Senior Regulatory Specialist! 🌟

We are seeking an experienced Senior Regulatory Specialist to ensure compliance with regulatory requirements and guide strategic regulatory decisions. The ideal candidate will have extensive knowledge of regulatory frameworks, excellent analytical skills, and the ability to navigate complex compliance landscapes while supporting business objectives.

📍 Location : Philadelphia, Pennsylvania

⏰ Work Mode :  Hybrid (2 times on-site / month)

What You'll Do :

  • Reviews and creates core documents (protocol, informed consent, investigator brochure, monitoring plans, etc.) and reports.
  • Prepare health authority submissions including meetings, new IND / IDE applications, and maintenance of these applications. Facilitate all communication with reviewing entities.
  • Ensure high quality of the research projects assigned and documentation is current and complete.
  • Review relevant safety information, obtain feedback from other parties, and identify potential impacts to other protocols / staff.
  • Inspection Readiness and facilitate audits of assigned projects.
  • Aware of legal agreements needed and / or planned and ensures appropriate information is included and addressed.
  • Assist in creating new operating procedures, work instructions, and templates.
  • Monitor regulatory news related to assigned activities, translate into operational changes as needed.
  • Provide guidance and training to faculty sponsors and staff.
  • Assist OCR Regulatory leadership with metrics and reports as assigned.
  • Other duties as assigned

What We're Looking For :

  • Bachelor’s degree and 5-7 years research experience required (at least 2 year’s regulatory experience preferred). Associated research credentialing (RAC, CCRP, CIP, etc.) are highly recommended or preferred to be completed within 1 year of employment.
  • Must have CMC manufacturing experience
  • Scientific knowledge and research design.
  • Thorough and demonstrated knowledge of Regulatory Framework and GXPs
  • Intermediate / expert level of function in all of the Microsoft Office applications, as well as

    • applications for team interconnectivity such as Microsoft Teams, Zoom, WebEx, etc.

    Preferred Qualification :

  • Knowledge and / or experience working with web-based e-regulatory document management systems such as Veeva Systems products, the Electronic Common Technical Document (eCTD), etc. is a plus.

    • Ready to make an impact? 🚀 Apply now and let's grow together!

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    Regulatory Specialist • Philadelphia, Pennsylvania, US

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