Associate Regulatory Affairs Analyst

4 weeks ago

Raleigh, United States augmentjobs Full time
Job DescriptionJob Description

Job Summary: The Associate Regulatory Affairs Analyst will support the regulatory affairs team in managing regulatory submissions, ensuring compliance with industry regulations, and facilitating the approval process for our products. This position is ideal for individuals with a keen interest in regulatory affairs and a desire to grow within a fast-paced environment.

Key Responsibilities:

  • Assist in preparing and submitting regulatory documentation for product approvals, renewals, and amendments.
  • Review and analyze regulatory requirements and guidelines to ensure compliance.
  • Maintain accurate and up-to-date regulatory files and databases.
  • Support the team in preparing responses to regulatory agency inquiries and requests.
  • Monitor regulatory changes and trends, and communicate relevant updates to the team.
  • Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to gather necessary information for regulatory submissions.
  • Conduct regulatory research and provide recommendations on regulatory strategies and pathways.
  • Assist in the preparation of regulatory compliance reports and documentation for internal and external stakeholders.

Qualifications:

  • Bachelor's degree in Life Sciences, Chemistry, Regulatory Affairs, or a related field.
  • 1-2 years of experience in regulatory affairs or a related field, preferably in [specific industry if applicable].
  • Knowledge of regulatory requirements and processes.
  • Strong analytical skills and attention to detail.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Preferred Qualifications:

  • Certification in Regulatory Affairs (e.g., RAC) or pursuit of certification.
  • Experience with [specific regulatory systems or tools, if applicable].

Benefits:

  • Competitive salary and performance-based incentives.
  • Health, dental, and vision insurance.
  • 401(k) plan with company match.
  • Paid time off and holidays.
  • Professional development opportunities and career growth.

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