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Title

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Regulatory Affairs Specialist

Description

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We are looking for a Regulatory Affairs Specialist to join our team and ensure that our products and processes comply with all relevant regulations and standards. In this role, you will play a critical part in navigating the complex regulatory landscape, ensuring that our products meet the necessary legal and safety requirements for market approval. You will collaborate with cross-functional teams, including research and development, quality assurance, and marketing, to provide regulatory guidance throughout the product lifecycle. As a Regulatory Affairs Specialist, you will be responsible for preparing and submitting regulatory documentation to authorities, monitoring changes in regulations, and advising the organization on compliance strategies. Your expertise will help us maintain our reputation for quality and safety while enabling us to bring innovative products to market efficiently. This position requires a strong understanding of regulatory frameworks, excellent communication skills, and the ability to manage multiple projects simultaneously. The ideal candidate will have a background in regulatory affairs, life sciences, or a related field, along with experience in preparing regulatory submissions and interacting with regulatory agencies. You should be detail-oriented, proactive, and capable of working in a fast-paced environment. If you are passionate about ensuring compliance and contributing to the success of a dynamic organization, we encourage you to apply.

Responsibilities

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  • Prepare and submit regulatory documentation to relevant authorities.
  • Monitor and interpret changes in regulatory requirements and standards.
  • Provide guidance to internal teams on regulatory compliance strategies.
  • Collaborate with cross-functional teams to ensure product compliance throughout the lifecycle.
  • Maintain up-to-date knowledge of industry regulations and best practices.
  • Communicate with regulatory agencies to address inquiries and obtain approvals.
  • Develop and implement regulatory policies and procedures.
  • Support audits and inspections by regulatory bodies.

Requirements

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  • Bachelor's degree in life sciences, regulatory affairs, or a related field.
  • 2+ years of experience in regulatory affairs or a similar role.
  • Strong knowledge of regulatory frameworks and compliance requirements.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects and meet deadlines.
  • Detail-oriented with strong organizational skills.
  • Proficiency in regulatory submission software and tools.
  • Experience interacting with regulatory agencies is a plus.

Potential interview questions

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  • Can you describe your experience with regulatory submissions?
  • How do you stay updated on changes in regulatory requirements?
  • Have you ever worked directly with regulatory agencies? If so, what was your role?
  • What strategies do you use to ensure compliance across multiple projects?
  • Can you provide an example of a challenging regulatory issue you resolved?