Regulatory Consultant

Ephi Gur Regulatory Consulting INC. is a specialized consulting firm that supports organizations in navigating complex regulatory environments, particularly within healthcare, pharmaceuticals, biotechnology, and related industries. The company provides guidance on regulatory strategy, compliance, submissions, and quality standards to help clients meet requirements set by agencies such as the FDA and other global regulatory bodies. The team focuses on accuracy, efficiency, and maintaining up to date knowledge of evolving regulations. We are looking for a Regulatory Consultant to support clients in achieving and maintaining compliance with applicable regulatory standards. This role involves preparing and reviewing regulatory submissions, interpreting guidelines, and advising on best practices throughout the product lifecycle. The ideal candidate is detail oriented, organized, and comfortable working with cross functional teams in a fast paced consulting environment.

Responsibilities

• Prepare and review regulatory submissions including IND, NDA, 510k, and other filings as applicable
• Interpret regulatory guidelines and communicate requirements to internal teams and clients
• Develop regulatory strategies to support product development and approval processes
• Monitor changes in regulations and assess impact on client projects
• Collaborate with quality assurance and clinical teams to ensure compliance across activities
• Maintain accurate documentation in accordance with regulatory standards and company procedures
• Support audits and inspections by preparing documentation and responding to inquiries
• Provide guidance to clients on regulatory risks, timelines, and submission expectations

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field
• Proven experience in regulatory affairs within pharmaceutical, biotech, or medical device industries
• Strong knowledge of FDA regulations and international regulatory frameworks
• Experience preparing and submitting regulatory documentation
• Excellent written and verbal communication skills
• Strong attention to detail and organizational skills
• Ability to manage multiple projects and meet deadlines
• Proficiency with document management systems and standard office software tools