Regulatory Affairs Specialist

Jobtailor

Kentucky

On-site

USD 90,000 - 120,000

Full time

5 days ago

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Job summary

Jobtailor is seeking a Regulatory Affairs professional to serve as a regulatory resource for complex molecules and distribution programs in a regulated environment.

You will assess FDA/DEA/state obligations and translate requirements into actionable controls, procedures, and monitoring activities across the organization.

Qualifications

Bachelor's degree or equivalent in life sciences, regulatory affairs, or related field.
3–5 years of regulatory affairs or quality/compliance experience in regulated environments.
Experience translating requirements into operational controls and procedures.
Experience supporting pharmaceutical distribution, specialty pharmacy, or 3PL operations.
Knowledge of DEA regulations, REMS, and cold-chain requirements.

Responsibilities

Serve as regulatory resource for complex molecules and distribution programs.
Assess FDA, DEA, state pharmacy, and manufacturer obligations.
Translate requirements into controls, procedures, and monitoring activities.
Identify gaps and conflicts across overlapping regulatory obligations.
Evaluate changes for regulatory impact and maintain documentation.
Support REMS programs, audits, and governance meetings.
Develop policies, SOPs, work instructions, and training materials.
Provide regulatory guidance to internal stakeholders and cross-functional teams.

Skills

Regulatory affairs

Quality assurance

Pharmaceutical distribution

Risk assessment

Operational controls

Compliance documentation

Investigative skills

Technical writing

Education

Bachelor's degree in Life Sciences or related field

Tools

Compliance Systems

Document management tools

Microsoft Office

Job description

Serve as a regulatory resource for complex molecules and specialized distribution programs
Assess product‑specific FDA, DEA, state pharmacy, manufacturer, quality, licensing, security, patient‑safety, and distribution obligations
Translate regulatory and manufacturer requirements into operational controls, procedures, decision criteria, and monitoring activities
Identify conflicts, gaps, dependencies, and unintended consequences across overlapping requirements
Evaluate process, system, facility, customer, and product changes for regulatory impact
Support implementation and maintenance of manufacturer REMS and restricted-distribution programs
Monitor REMS exceptions, metrics, customer eligibility outcomes, and compliance trends
Support manufacturer audits, governance meetings, program reviews, corrective actions, and remediation
Develop and revise policies, SOPs, work instructions, job aids, and training materials
Support controlled‑substance compliance, investigations, documentation, and notification activities
Lead or support regulatory assessments for new specialty products, biologics, cell and gene therapies, and complex therapies
Participate in launch‑readiness reviews and confirm controls, documentation, training systems, and escalation paths
Monitor regulatory and manufacturer program developments and perform impact assessments
Investigate compliance concerns, complaints, deviations, and process failures
Lead or support root cause analysis and corrective and preventive actions
Maintain documentation for regulatory interpretations, risk decisions, investigations, and compliance assessments
Support FDA, DEA, state board, manufacturer, client, and internal audits or inspections
Provide regulatory guidance and training to internal stakeholders
Facilitate cross‑functional issue resolution and communicate with manufacturers and external program administrators
Participate in business‑development and client‑onboarding activities requiring specialized regulatory expertise

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Supply Chain, Healthcare Administration, or a related field; equivalent experience may be considered
3–5 years of relevant experience in regulatory affairs, quality assurance, pharmaceutical distribution, healthcare compliance, pharmaceutical manufacturing, or a related regulated environment
Experience interpreting regulatory, quality, manufacturer, or customer requirements and translating them into operational controls
Experience supporting pharmaceutical distribution, specialty pharmacy, wholesale distribution, manufacturer, or 3PL operations
Experience investigating complex issues, documenting risk‑based decisions, and coordinating corrective actions across functions
Experience supporting REMS products, restricted‑distribution programs, specialty pharmaceuticals, biologics, cell and gene therapies, or other complex therapies
Knowledge of DEA controlled substance regulations and state board of pharmacy requirements
Familiarity with cold‑chain, ultra‑low‑temperature, chain‑of‑custody, or specialty logistics requirements
Experience with product commercialization, launch readiness, regulatory change implementation, or manufacturer program onboarding
Experience interacting with pharmaceutical manufacturers, auditors, regulatory agencies, program administrators, or external business partners
Regulatory Affairs Certification (RAC), pharmacy technician certification, or a comparable professional credential
Strong working knowledge of pharmaceutical regulatory compliance and specialized distribution controls
Ability to interpret overlapping regulatory, manufacturer, quality, licensing, and operational requirements
Ability to distinguish legal requirements, regulatory expectations, contractual commitments, and internal best practices
Strong analytical, investigative, technical‑writing, documentation, and problem‑solving skills
Ability to perform risk assessments, identify control gaps, and recommend mitigation actions
Excellent written and verbal communication skills
Ability to manage multiple priorities, lead workstreams, drive follow‑up, and influence stakeholders without direct authority
Proficiency with compliance systems, document management tools, investigation records, metrics, and Microsoft Office applications

Core Competencies

Demonstrates expertise in regulatory affairs, compliance, and quality assurance within the pharmaceutical industry, with a strong focus on managing complex therapies and specialized distribution programs. Proficient in translating regulatory requirements into operational controls and conducting thorough risk assessments.

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