Regulatory Affairs Manager: Navigating Global Healthcare Compliance

9 hours ago

Canada Advanced Clinical Full time

Job Overview

We are seeking an experienced Regulatory Affairs Manager to join our team at Advanced Clinical. This part-time position will be based in Canada and will play a crucial role in developing and implementing global regulatory strategies for contracted clinical programs.

About Us

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation.

Key Responsibilities

Serving as the primary point of contact for assigned projects and with regulatory agenciesPlanning, directing, and/or coordinating regulatory activities to ensure compliance with regulations and standard operating procedures
  • Developing and reviewing regulatory strategies and plans to ensure continued access to products globally
  • Preparing, submitting, and maintaining product information for regulatory authorities
  • Managing regulatory agency submissions (eCTD, IND applications, Clinical Trial, NDAs, BLAs, MAA's, Amendments, Variations, Renewals)
  • Monitoring emerging trends within the global regulatory environment to determine potential impacts on organizational processes

Requirements

To be successful in this role, you will need:

  • A minimum of 5+ years of relevant regulated industry experience (MedTech/Pharma/CRO)
  • Significant experience in all aspects of meeting and communicating with Regulatory/Health Authorities supporting drug development
  • Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables
  • Expert knowledge of the applicable regulatory framework as applied to different healthcare sectors such as for Drugs and Medical Devices

What We Offer

We offer a competitive salary of $90,000 per year, plus additional benefits and opportunities for professional growth and development. If you are passionate about navigating global healthcare compliance and have a strong background in regulatory affairs, we encourage you to apply for this exciting opportunity.

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