Regulatory Affairs Specialist

Required Licensure

• Active and unrestricted Pharmacist License in at least one U.S. state.

Required Experience

• Minimum 3–5 years of experience in regulatory affairs, clinical trial operations, pharmaceutical compliance, clinical supply chain, or related pharmaceutical industry experience.
• Experience reviewing pharmaceutical labeling and regulatory documentation.
• Experience supporting global clinical trials and investigational products preferred.

Knowledge, Skills, and Abilities

• Strong knowledge of pharmaceutical regulations and clinical trial requirements.
• Understanding of investigational product labeling regulations and country-specific requirements.
• Knowledge of importation, exportation, customs, and regulatory documentation processes.
• Ability to interpret and apply complex regulatory requirements across multiple jurisdictions.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Proficiency with Microsoft Office and regulatory document management systems.

Preferred Experiencenice to have

• Knowledge of FDA, EMA, MHRA, Health Canada, SAHPRA, and other international regulatory frameworks.
• Experience with clinical trial import/export requirements and global distribution activities.
• Experience working with GxP environments, including GCP, GDP, and GMP requirements.
• Experience supporting multinational clinical trials.

Preferred Certificationsnice to have

• Regulatory Affairs Certification (RAC)
• Certified Clinical Research Professional (CCRP) or equivalent
• Additional certifications in regulatory affairs, quality systems, or clinical research preferred

Importation and Exportation Support

• Provide regulatory consultation regarding importation and exportation requirements for investigational products and clinical trial materials.
• Evaluate country-specific documentation requirements to support customs clearance and regulatory approvals.
• Advise project teams on Certificates of Pharmaceutical Product (CPP/CoPP), GMP certificates, Certificates of Analysis, stability documentation, and other regulatory submissions required for importation.
• Support resolution of regulatory issues affecting international shipments.

Clinical Trial Supply Support

• Collaborate with clinical supply chain teams to ensure regulatory requirements are incorporated into supply planning and distribution strategies.
• Support assessment of country activation requirements related to study drug importation and distribution.
• Provide regulatory guidance for depot-to-site and direct-to-site distribution models.
• Participate in risk assessments associated with global supply chain activities.

Regulatory Intelligence and Documentation

• Monitor and interpret changes in global pharmaceutical regulations that may impact clinical trial operations.
• Develop and maintain regulatory guidance documents, country requirement summaries, and compliance tools.
• Support audits, inspections, and regulatory inquiries by providing subject matter expertise and required documentation.
• Maintain records of regulatory assessments and recommendations in accordance with quality system requirements.

Stakeholder Support

• Serve as a regulatory SME for sponsors, project managers, supply chain personnel, and quality teams.
• Participate in sponsor meetings and provide regulatory updates and recommendations.
• Support process improvement initiatives and implementation of best practices related to regulatory compliance.

Typical Scope of Responsibility

• Medical, dental and vision plans

• At least 120 hours PTO and 10 paid holidays

• Paid parental leave

• 401(k) retirement savings plan

• Employee Stock Purchase Plan

• Tuition reimbursement

Environmental Conditions