Regulatory Manager

Avient•Avon Lake, OH

About The Position

The Regulatory Manager leads the U.S. regulatory team and oversees compliance of food, drug, and medical products with applicable requirements established by the FDA, EU, and other international authorities. The role drives regulatory strategy, mentors team members, and collaborates with cross-functional leaders to meet business objectives compliantly and efficiently. The manager monitors and interprets regulations; advises on labeling, packaging, advertising, and regulatory risk; and oversees review of formulations, manufacturing processes, and packaging. The role directs complex regulatory submissions, manages product dossiers, and serves as the primary liaison with regulatory agencies. It leads regulatory activities throughout the product lifecycle, establishes adherence to cGMP, GCP, and other standards, and assesses regulatory changes and business impacts. The position oversees risk assessments, audits, inspections, and CAPA implementation; develops the U.S. regulatory team; leads cross-functional regulatory collaboration; and provides regulatory training. It also oversees post-market surveillance, investigates adverse events or product issues, and leads reporting of adverse events, recalls, and safety issues.

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 proven ability to manage multiple priorities and tasks.
Results-oriented approach.
Effective analytical and problem-solving skills.
Strong team-player skills.
Personal ethics and integrity.

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 jurisdictions; communicate changes and recommend strategic adjustments.
Provide regulatory guidance on labeling, packaging, advertising, and risk management.
Oversee and approve reviews of product formulations, manufacturing processes, and packaging activities.
Direct preparation, review, and submission of regulatory documents, including INDs, NDAs, ANDAs, and food product registrations.
Oversee product dossiers for approvals, renewals, and amendments, and establish documentation and communication best practices.
Lead interactions with regulatory agencies, including during product approval, and address complex questions.
Manage regulatory aspects of the product lifecycle from concept and development through post-market surveillance.
Establish and enforce adherence to cGMP, GCP, and relevant regulatory standards.
Track and evaluate regulatory changes, assess their impact on operations and project pipelines, and provide risk-mitigation guidance.
Oversee regulatory risk assessments and develop mitigation strategies.
Lead and coordinate internal and external audits and continuous improvement initiatives.
Direct regulatory inspections, response strategies, and CAPA implementation.
Lead, coach, and develop the U.S. regulatory team.
Lead cross-functional teams to integrate regulatory strategy into product development and commercialization.
Develop and deliver regulatory training and guidance.
Oversee post-market surveillance and investigations into adverse events or product issues.
Lead reporting of adverse events, recalls, and product safety issues to authorities and stakeholders.