Regulatory Affairs Associate Consultant

Job Title: Regulatory Associate Consultant

Employment Type: 12- 18 months Contract

Location: Remote

DUTIES & RESPONSIBILITIES:

We are currently seeking a highly motivated and experienced Regulatory Specialist with expertise in US OTC (Over-the-Counter) monographs to join our Regulatory Affairs team. As a Regulatory Specialist, you will play a crucial role in ensuring compliance with regulatory requirements, specifically focusing on US OTC monographs. The ideal candidate will possess a deep understanding of regulatory frameworks, attention to detail, and the ability to navigate complex regulatory landscapes.

Job Responsibilities

• With the support of RA Managers, review and provide feedback on client documentation related to US Cough and Cold monograph products.
• Provide support with regards to the review of the following topics under US OTC Monographs
  • Labeling
  • Claims
  • Monograph requirements
  • Advertising
  • Assessing competitive products against monograph claims
• Collaborate with cross-functional teams
• Stay current with evolving regulations, guidelines, and industry trends related to OTC monographs.
• Provide regulatory guidance to internal teams to ensure compliance throughout the product lifecycle
• Manage timelines and client expectations by clearly understanding and communicating requests.

Skills / Experience

• Bachelor or Master Degree in Science, Medicine, Pharmacology, Engineering, Chemistry, or equivalent education
• At least 2 years’ experience with US Pharmaceutical regulations is required with a focus on US OTC monographs
• Proven knowledge of FDA regulations, guidelines, and requirements related to OTC products.
• Ability to understand and interpret regulatory and technical documents.
• Proficient in oral and written communication, and in Microsoft Office (Word, Excel, PowerPoint), with good planning and organization skills
• Self-starter with an ability to work in team environment and on problems of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
• Strong critical thinking and analytical skills.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity