Regulatory Affairs Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

The position works closely with sponsors, clinical supply teams, manufacturers, depots, CROs, and regulatory authorities to facilitate compliant product distribution, review labeling materials, and provide regulatory guidance throughout the clinical trial lifecycle.

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.

Qualifications:

Required Education

• Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an accredited institution.

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.

Preferred Experience

• 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.

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 Certifications

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

Typical Scope of Responsibility

The Regulatory Affairs Specialist serves as a key regulatory resource supporting global clinical trial supply operations. The role is responsible for ensuring compliance with country-specific regulatory requirements, reducing risks associated with international product distribution, supporting sponsor objectives, and maintaining regulatory readiness throughout the clinical trial lifecycle. This position exercises independent judgment and provides expert recommendations that directly impact study timelines, product distribution, and regulatory compliance

Compensation and Benefits

The salary range estimated for this position based in Maryland is $83,300.00-$125,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards