Regulatory Compliance Officer

Job Description

Job Description

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 OTC and Rx drug products.
• Work closely with CMOs to ensure compliance with cGMP , FDA regulations, and company standards.
• Assist in the review, approval, and maintenance of SOPs , batch records, and release documentation.
• 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, including FDA and state licensing renewals .
• 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:

• 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.
• Strong knowledge of FDA and State Board of Pharmacy regulations and licensing .
• Knowledge of 21 CFR Part 7 (Recalls), Part 11 (Electronic Records), and Parts 210/211 (cGMP for Processing, Packing, or Holding of Drugs) .
• 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.

This now includes:

• FDA and State licensing renewals
• Compliance tracking and documentation
• Audit readiness
• SOP and policy development
• Cross-functional liaison and stakeholder support
• DSCSA knowledge and specific FDA regulations

iON Pharma USA is a pharmaceutical company committed to innovation, collaboration, and continuous development. We are at the forefront of the pharmaceutical industry, constantly pushing boundaries and driving positive change. Our diverse and inclusive culture fosters creativity and excellence, providing our employees with a thrilling journey of growth and achievement. We uphold the highest ethical standards, celebrate diversity, and ensure that every voice is heard and valued.

Company Description

iON Pharma USA is a pharmaceutical company committed to innovation, collaboration, and continuous development. We are at the forefront of the pharmaceutical industry, constantly pushing boundaries and driving positive change. Our diverse and inclusive culture fosters creativity and excellence, providing our employees with a thrilling journey of growth and achievement. We uphold the highest ethical standards, celebrate diversity, and ensure that every voice is heard and valued.