Regulatory Affairs Specialist
Thermo Fisher
Summary
The Regulatory Affairs Specialist (Licensed Pharmacist) provides regulatory expertise to support the global distribution, labeling, importation, exportation, and compliance activities associated with clinical trial materials and investigational products under the CRPMC contract. This role serves as a subject matter expert (SME) for country-specific pharmaceutical regulations, clinical trial supply requirements, and investigational product labeling requirements, ensuring compliance with applicable regulatory authorities and supporting uninterrupted clinical trial operations.
Job description
Position Summary
The Regulatory Affairs Specialist (Licensed Pharmacist) provides regulatory expertise to support the global distribution, labeling, importation, exportation, and compliance activities associated with clinical trial materials and investigational products under the CRPMC contract. This role serves as a subject matter expert (SME) for country-specific pharmaceutical regulations, clinical trial supply requirements, and investigational product labeling requirements, ensuring compliance with applicable regulatory authorities and supporting uninterrupted clinical trial operations.
Essential Duties and Responsibilities
Regulatory Compliance and Labeling
- Review investigational product labels, label artwork, and label proofs for compliance with country-specific regulatory requirements.
- Assess labeling content, format, language requirements, storage statements, and regulatory disclosures applicable to destination countries.
- Prepare documented regulatory reviews identifying compliance status, deficiencies, and recommended corrective actions.
- Maintain awareness of evolving global regulatory requirements affecting clinical trial labeling and supply distribution.
- Provide citation-supported regulatory assessments and recommendations based on applicable regulations and guidance documents.
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.
Requirements
- Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an accredited institution
- Active and unrestricted Pharmacist License in at least one U.S. state
- 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
- 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
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- 401(k) Matching
- Employee Stock Purchase Plan
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.