Regulatory Manager

Avient•Avon Lake, OH

About The Position

The Regulatory Manager leads the U.S. regulatory team and oversees compliance for food, drug, and medical products with applicable requirements established by the FDA, EU, and other international regulatory authorities. The role drives regulatory strategy, mentors team members, and collaborates with cross-functional leaders to meet business objectives in a compliant and efficient manner. The manager leads regulatory strategy and compliance, directs regulatory submissions and agency interactions, and oversees regulatory requirements throughout the product lifecycle. The role also leads risk management, audits, inspections, post-market surveillance, adverse-event reporting, and regulatory training. The position works closely with R&D, quality assurance, marketing, and manufacturing and is responsible for developing the capabilities of the U.S. regulatory team. The position requires prolonged periods in a stationary position, frequent communication, and the ability to move through and operate a computer and other office equipment. Work is typically performed in an office environment with low to moderate noise. Avient requires employees to comply with applicable environmental, health, safety, and security requirements and report EHS&S incidents immediately.

Requirements

Bachelor’s degree.
5–10 years of experience in manufacturing, regulatory, or environmental health and safety.
Excellent working knowledge of computer software applications, including Microsoft Office.
Excellent verbal and written communication skills.
Excellent interpersonal skills and ability to interface effectively at all organizational levels.
Project management skills.
Effective listening skills.
Conflict resolution skills.
Strong organizational skills and demonstrated ability to manage multiple priorities and tasks.
Results-oriented approach.
Effective analytical and problem-solving skills.
Strong team-player skills.
Personal ethics and integrity.
Ability to remain stationary for prolonged periods and communicate frequently.
Ability to traverse and operate a computer and other office equipment.

Nice To Haves

Proficiency in SAP.

Responsibilities

Monitor and interpret evolving regulations and guidelines for food, drugs, and medical devices in the U.S., EU, and other global jurisdictions; communicate changes and recommend strategic adjustments.
Provide regulatory guidance on labeling, packaging, advertising, and regulatory risk management.
Oversee and approve reviews of product formulations, manufacturing processes, and packaging activities for regulatory compliance.
Direct the preparation, review, and submission of complex regulatory documents, including INDs, NDAs, ANDAs, and food product registrations.
Oversee product dossiers for regulatory approvals, renewals, and amendments, and establish documentation and communication best practices across global markets.
Serve as the main liaison with regulatory agencies, lead interactions during product approvals, address complex questions, and advocate for company interests.
Lead regulatory activities across the product lifecycle, from concept and development through post-market surveillance.
Establish and enforce adherence to current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulatory standards.
Track and evaluate regulatory changes, assess their effects on operations and project pipelines, and provide risk-mitigation guidance.
Oversee regulatory risk assessments, develop mitigation strategies, and support risk-based decisions for product development and commercialization.
Lead and coordinate internal and external audits and drive continuous improvement initiatives.
Direct regulatory inspections, manage response strategies, and oversee corrective and preventive actions (CAPA).
Lead, coach, and develop the U.S. regulatory team; set priorities and strengthen team capabilities.
Lead cross-functional teams, including R&D, quality assurance, marketing, and manufacturing, to embed regulatory strategy in product development and commercialization.
Develop and deliver regulatory training and guidance to keep departments current on regulations, best practices, and company policies.
Oversee post-market surveillance and investigate adverse events or product issues.
Lead reporting of adverse events, recalls, or product safety issues to authorities and stakeholders, ensuring timely documentation and communication.
Comply with applicable EHS&S requirements and report EHS&S incidents immediately.