FDA Quality and Regulatory Specialist

About iON Pharma USA:

iON Pharma USA is a growing pharmaceutical company focused on developing and distributing high-quality OTC and prescription (Rx) products. We are seeking an experienced Regulatory Compliance professional (In-House or Consultant) to support our operations, ensure full compliance with FDA and state regulations, and collaborate with our contract manufacturing organizations (CMOs) and licensing partners.

Key Responsibilities:

• Oversee and manage all regulatory compliance activities related to drug products and supplements.
• Work closely with CMOs to ensure compliance with cGMP
  , FDA regulations, and company standards.
• Assist in the generation, review, approval, and maintenance of SOPs
  , batch records, release documentation, and overall quality management system.
• Support product registration, ANDA submissions
  , and other regulatory filings with the FDA and international authorities.
• Ensure all required regulatory filings and reports are completed by the appropriate internal teams or third-party providers.
• Track and maintain records confirming timely completion and submission of all regulatory documentation.
• Coordinate and oversee batch release
  , ensuring compliance with labeling, packaging, and quality standards.
• Coordinate preparation of SPL (Structured Product Labeling) for drug products and manage annual drug listings in accordance with FDA requirements.
• Update and maintain product labeling and artwork to ensure compliance with regulatory and branding standards.
• Manage and maintain GS1 traceability systems and track & trace compliance for product serialization.
• Collaborate with partner companies for licensing agreements
  , product transfers, and regulatory due diligence.
• Monitor internal processes and collaborate with relevant departments (e.g., operations, quality, controls, waste, and customer service) to verify compliant handling, storage, transportation, and disposal of pharmaceutical products, including hazardous waste
  .
• Act as a liaison between departments to identify and resolve compliance-related issues.
• Provide support and guidance to internal stakeholders on regulatory expectations and procedures.
• Help develop and implement SOPs and internal compliance protocols
  .
• Participate in regulatory inspections and client audits by coordinating documentation, facilitating interviews, and supporting corrective action follow-ups.
• Maintain audit readiness through regular internal reviews and document control.
• Stay informed of changes in regulatory requirements and assess their impact on company operations.
• Support the implementation of policy updates and process improvements as needed.
• Qualifications of Contract manufactures

Qualifications:

• Bachelor’s degree in Regulatory Affairs, Life Sciences, or a related field.
• 3+ years of experience in a compliance or regulatory role in the pharmaceutical, life sciences, or healthcare distribution industry.
• Knowledge of FDA Quality and regulations and licensing
  .
• Knowledge of 21 CFR, GMP, and other applicable regulatory frameworks.
• Knowledge of FDA requirements applicable to DSCSA (Drug Supply Chain Security Act).
• Experience supporting regulatory audits and client inspections
  .
• Excellent organizational, communication, and cross-functional collaboration skills.
• Ability to manage deadlines and compliance calendars effectively.
• Proficient in Microsoft Office 365 and compliance tracking systems.