Job Title: Pharmaceutical Regulatory Consultant - Lipid
Rosemont, IL 60018 - Hybrid
12+ Months
Job Summary:
We are seeking an experienced Regulatory Affairs Consultant with specialized knowledge in lipid-based pharmaceutical products, particularly Fish Oil Triglycerides such as EPA/DHA omega-3 fatty acids. The consultant will provide regulatory support and strategic guidance for drug, dietary supplement, or nutraceutical products containing fish oil derivatives, ensuring compliance with global regulatory standards including FDA (CDER & CFSAN). The Regulatory Affairs Consultant will serve as an essential resource within the organization, providing technical expertise and regulatory guidance for the development, manufacturing, and commercialization of lipid-based pharmaceutical products. Strong cross-functional collaboration and communication skills are required to ensure alignment across teams, alongside a deep understanding of regulatory pathways for these products.
Department: Regulatory Affairs
Reports To: Vice President
Key Responsibilities:
• Develop and implement regulatory strategies for small molecules for US market
• Prepare, review, and manage regulatory submissions including, ANDAs, NDAs
• Provide CMC regulatory input, with a focus on: Q1, Q2, Q3 and IVRT approach, stability, oxidation control, and impurity profiling , manufacturing process validation and GMP compliance
• Interpret and apply relevant regulatory guidelines: FDA guidance on combination products, Q1-Q2, Q3 Characterization
• Support Labeling, Claims, and Advertising Compliance, ensuring alignment with 21 CFR Part 101 and Part 201
• EFSA and Codex Alimentarius regulations (for international markets)
• Address regulatory queries and deficiency letters from agencies and coordinate prompt responses.
• Collaborate with R&D, Quality, Manufacturing, and Marketing teams to ensure regulatory alignment throughout the product lifecycle. Offer technical expertise in development, testing, and manufacturing processes, including compatibility testing, stability studies, process validation, and cleaning validation.
• Stay informed on emerging trends, regulations, and technologies related to Lipid products to identify opportunities for process improvements and streamline regulatory processes.
• Prepare and submit applications for lipid products to regulatory agencies, primarily the US FDA, ensuring timely and accurate submissions.
• Assess regulatory reporting requirements using FDA regulations, guidance documents, and in-house policies for change control documentation
• Develop and maintain regulatory trackers and databases to monitor submission timelines, track regulatory changes, and communicate updates to relevant stakeholders.
• Partner with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to compile required information and ensure compliance for all new products, changes to existing products, and post-market activities.
Qualifications:
• Bachelor’s degree in Life Sciences, Regulat ory Affairs, Chemistry, Engineering or a related
field. Advanced degrees or certifications in Regulatory Affairs (e.g., RAC) are a plus.
• Minimum of 3-5 years of experience in the regulatory field within the pharmaceutical
industry, including 3+ years working with ANDA’s
• Strong understanding of the regulatory pathways for both Rx and non-Rx products (including
505(b)(2), ANDA, GRAS, NDI).
• Familiarity with eCTD software, regulatory databases, and GMP documentation.
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