Regulatory Manager

Avient•Avon Lake, OH

About The Position

The Regulatory Manager will be accountable for leading and overseeing the compliance of our food, drug, and medical products with all applicable regulatory requirements, including but not limited to those established by the FDA, EU, and other international regulatory authorities. The Regulatory Manager will drive regulatory strategy, mentor team members, and collaborate closely with cross-functional leadership to ensure business objectives are met in a compliant and efficient manner.

Requirements

Experience leading and overseeing the compliance of food, drug, and medical products with applicable regulatory requirements (FDA, EU, international).
Experience driving regulatory strategy.
Experience mentoring team members.
Experience collaborating with cross-functional leadership.
Expertise in U.S. (FDA), EU, and other global regulatory requirements for food, drugs, and medical devices.
Experience providing strategic guidance on labeling, packaging, advertising, and regulatory risk management.
Experience overseeing and approving product formulations, manufacturing processes, and packaging for regulatory adherence.
Experience directing the preparation, review, and submission of regulatory documents (INDs, NDAs, ANDAs, food product registrations).
Experience managing product dossiers for regulatory approvals, renewals, and amendments.
Experience acting as a liaison with regulatory agencies (FDA, EMA, etc.).
Experience managing the regulatory aspects of the product lifecycle (concept, development, post-market surveillance).
Experience establishing and enforcing adherence to cGMP and GCP.
Experience tracking and evaluating regulatory changes and assessing their impact.
Experience overseeing and directing regulatory risk assessments and developing mitigation strategies.
Experience leading and coordinating internal and external audits.
Experience directing regulatory inspections and managing response strategies.
Experience developing and delivering regulatory training programs.

Responsibilities

Lead the monitoring and interpretation of evolving regulations and guidelines for food, drugs, and medical devices in the U.S. (FDA), EU, and other global jurisdictions; proactively communicate changes and recommend strategic adjustments.
Serve as regulatory expert and advisor, providing strategic guidance on labeling, packaging, advertising, and overall regulatory risk management to ensure full compliance and protect company interests.
Oversee and approve the review of product formulations, manufacturing processes, and packaging activities to ensure full adherence to all applicable food, drug, and medical device regulations.
Direct the preparation, review, and submission of complex regulatory documents (including INDs, NDAs, ANDAs and food product registrations) and ensure high-quality, timely submissions.
Oversee the management of product dossiers for regulatory approvals, renewals, and amendments, establishing best practices for documentation and communication across global markets.
Act as the main liaison with regulatory agencies (FDA, EMA, etc.), leading interactions during product approval, addressing complex questions, and advocating for the company’s interests.
Lead and manage the regulatory aspects of the product lifecycle, from concept and development through post-market surveillance, ensuring compliance and regulatory readiness at every stage.
Establish and enforce company-wide adherence to current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and all relevant regulatory standards for food, drug, and medical device products.
Lead efforts to track and evaluate regulatory changes, and assess the impact on business operations and project pipelines, providing guidance and solutions to mitigate risks.
Oversee and direct regulatory risk assessments, develop mitigation strategies, and support risk-based decision-making for product development and commercialization.
Lead and coordinate internal and external audits, ensuring enterprise-wide compliance with FDA and international regulations, and drive continuous improvement initiatives.
Direct regulatory inspections, manage response strategies, and oversee implementation of corrective and preventive actions (CAPA).
Lead cross-functional teams—including R&D, quality assurance, marketing, and manufacturing—to embed regulatory strategy into all phases of product development and commercialization.
Develop and deliver regulatory training programs and guidance to ensure all departments are up-to-date on current regulations, best practices, and company policies.
Oversee post-market surveillance activities, ensuring continuous monitoring of product performance and regulatory compliance, and lead investigations into adverse events or product issues.
Lead the reporting of adverse events, recalls, or product safety issues to authorities and stakeholders, ensuring timely and thorough documentation and communication.