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Job Description

Title: Regulatory Affairs Specialist

Reports to: Director of Quality & Regulatory

Position Summary
The Regulatory Affairs Specialist ensures that all company products meet applicable regulatory requirements by coordinating internal procedures, conducting audits, facilitating inspections, managing license renewals, and maintaining registrations. This position is responsible for compiling, reviewing, and submitting required documentation to regulatory agencies, with a primary focus on the pharmaceutical sector. The role demands attention to detail, strong organizational skills, and the ability to interpret and apply complex regulations to business operations.

Essential Responsibilities
• Prepare and submit regulatory applications, reports, and correspondence to relevant agencies.
• Identify required regulatory documentation and ensure completeness, accuracy, and timeliness of submissions.
• Provide regulatory guidance to cross-functional teams on product design, development, labeling, and marketing activities.
• Support the implementation and maintenance of regulatory policies and procedures to ensure compliance.
• Communicate regulatory requirements across departments and ensure consistent interpretation.
• Participate in audits, inspections, and product recall activities as required.
• Contribute to regulatory strategies for new product submissions.
• Respond to regulatory inquiries and requests for product information.
• Assist in investigating and documenting product complaints and preparing related submissions.
• Help maintain efficient complaint handling systems to ensure prompt resolutions.
• Monitor, analyze, and communicate changes to relevant regulations, including proposed and final rules.
• Maintain technical files to obtain and sustain product approvals and registrations.
• Prepare and distribute regulatory reports to management.
• Serve on internal committees and participate in special projects as assigned.
• Conduct annual product reporting and track CDER updates.
• Prepare ingredient listings, Supplement Facts, and Drug Facts panels.
• Review artwork for regulatory compliance.
• Maintain professionalism and discretion when handling confidential information.

Qualifications

Knowledge, Skills & Abilities
• Strong understanding of GMPs and regulations from FDA, CMS, and FTC.
• Familiarity with pharmaceutical and cosmetic regulatory standards.
• Ability to interpret and apply federal and state regulations to internal processes.
• Strong judgment and problem-solving abilities; able to resolve issues and escalate as necessary.
• Ability to manage multiple projects and meet deadlines.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and aptitude for learning new systems.
• Excellent verbal, written, and interpersonal communication skills in English.
• Strong mathematical skills, including ability to analyze and interpret statistical data.

Education & Experience
• Bachelor’s degree in Regulatory Affairs, Pharmaceutical Science, Chemistry, or related field (Master’s preferred).
• Minimum 2 years of regulatory affairs experience in a pharmaceutical manufacturing environment.
• Experience with SPL submissions is required for this role. Experience with Abbreviated New Drug Application (ANDA) and ECTD submissions is preferred.

Physical Demands & Work Environment
• Work performed primarily in FDA- and DEA-regulated laboratory and office settings with potential exposure to chemicals used in pharmaceutical, nutritional supplement, and cosmetic manufacturing.
• May be exposed to distractions such as noise, paging systems, and routine office interruptions.
• Requires mobility within the facility and occasional travel to nearby company locations.
• Ability to sit or stand for up to 8 hours, lift up to 20 lbs., bend, stoop, reach, push, pull, and use standard office and laboratory equipment.
• Exposure to typical office chemicals (toner, adhesives, etc.) and controlled manufacturing substances in limited circumstances.