Regulatory Affairs Associate Analyst

2 weeks ago


Raleigh, North Carolina, United States augmentjobs Full time
Job Overview

Position Summary: The Regulatory Affairs Associate Analyst will play a crucial role in assisting the regulatory affairs department with the management of regulatory submissions, ensuring adherence to industry standards, and streamlining the approval processes for our offerings. This role is perfect for candidates who are passionate about regulatory affairs and eager to advance in a dynamic setting.

Primary Responsibilities:

  • Support the preparation and submission of regulatory documents for product approvals, renewals, and modifications.
  • Evaluate and interpret regulatory requirements and guidelines to guarantee compliance.
  • Keep regulatory files and databases organized and current.
  • Assist in formulating responses to inquiries and requests from regulatory agencies.
  • Track changes and developments in regulations, providing relevant updates to the team.
  • Work collaboratively with various departments, including Research & Development, Quality Assurance, and Marketing, to collect necessary information for regulatory submissions.
  • Conduct research on regulatory matters and offer insights on regulatory strategies and pathways.
  • Help prepare compliance reports and documentation for both internal and external stakeholders.

Required Qualifications:

  • Bachelor's degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline.
  • 1-2 years of experience in regulatory affairs or a related area, ideally within a specific industry.
  • Familiarity with regulatory requirements and processes.
  • Strong analytical abilities and meticulous attention to detail.
  • Exceptional written and verbal communication skills.
  • Capability to manage multiple priorities effectively in a fast-paced environment.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Preferred Qualifications:

  • Certification in Regulatory Affairs (e.g., RAC) or in the process of obtaining certification.
  • Experience with specific regulatory systems or tools, if applicable.

Benefits:

  • Competitive salary with performance-based incentives.
  • Comprehensive health, dental, and vision insurance.
  • 401(k) plan with company matching.
  • Paid time off and holidays.
  • Opportunities for professional development and career advancement.


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