Pharmaceutical Regulatory Consultant - Remote

Overview

We are seeking a Pharmaceutical Regulatory Consultant to provide expert guidance on regulatory strategy, compliance, and process standardization. This role involves planning, leading, and implementing regulatory frameworks while supporting clients through the development and submission of regulatory applications.

In Short

• Develop and implement regulatory strategies to ensure compliance with FDA, EMA, ICH, and other global regulatory standards.
• Lead cross-functional teams in preparing for regulatory submissions, approvals, and inspections.
• Assess and interpret regulations to provide actionable recommendations.
• Establish, document, and maintain standard operating procedures (SOPs).
• Monitor and evaluate regulatory risks, proposing solutions to address challenges.
• Represent clients in regulatory agency meetings and audits.
• Provide guidance on quality systems implementation.

Requirements

• Minimum 5 years of experience in regulatory affairs or compliance.
• Strong knowledge of FDA, EMA, ICH, and global regulatory guidelines.
• Bachelor's or advanced degree in life sciences or pharmacy preferred.
• Regulatory Affairs Certificate (RAC) required.
• Proven experience in regulatory strategy and risk assessment.
• Exceptional leadership and organizational skills.
• Strong communication and interpersonal skills.
• Proficiency in regulatory compliance tools and project management software.

Benefits

• Flexible working hours.
• Opportunity to work with leading pharmaceutical and biotech organizations.
• Impactful projects that shape the future of healthcare.
• Remote work opportunity.