Pharmaceutical Regulatory Consultant

Pharmaceutical Regulatory Consultant 

  Employment Type: Remote 1099 Contractor (Part-Time or Full-Time) 

At Criterion Edge, we empower healthcare companies to deliver innovative solutions through regulatory excellence. By leveraging expertise in global regulatory processes, we assist clients in navigating compliance challenges and achieving regulatory goals with precision and efficiency. Join us in shaping the future of healthcare by driving impactful projects for leading pharmaceutical and biotech organizations. 

Position 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. The ideal candidate will have extensive knowledge of global regulatory requirements, hold a Regulatory Affairs Certificate (RAC), and demonstrate the ability to guide cross-functional teams through complex regulatory landscapes. 

Key Responsibilities 

• 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 on documents such as Biologics License Applications (BLA), New Drug Applications (NDA), Investigational New Drug (IND) applications, and electronic Common Technical Document (eCTD) modules. 

• Assess and interpret regulations to provide actionable recommendations and ensure compliance throughout the product lifecycle. 

• Establish, document, and maintain standard operating procedures (SOPs) for regulatory processes and submissions. 

• Monitor and evaluate regulatory risks, proposing solutions to address challenges and align with regulatory expectations. 

• Represent clients in regulatory agency meetings, facilitating discussions and providing support during audits or reviews. 

• Provide guidance on the implementation of quality systems and ensure regulatory readiness across projects. 

Qualifications and Skills 

• Minimum 5 years of experience in regulatory affairs, compliance, or related roles in the pharmaceutical or biotech industry. 

• Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and processes. 

• Bachelor’s or advanced degree in life sciences, pharmacy, or a related field preferred. 

• Regulatory Affairs Certificate (RAC) required. 

• Proven experience in regulatory strategy, risk assessment, and process optimization. 

• Exceptional leadership and organizational skills to manage multiple projects and teams. 

• Strong communication and interpersonal skills for liaising with regulatory bodies and cross-functional teams. 

• Proficiency in regulatory compliance tools, quality management systems, and project management software.