Regulatory Manager

Avient Corporation; Avon Lake (OH); On-site; USD 140,000 - 170,000; Full time

Job summary

Avient Corporation is seeking a Regulatory Manager to lead the U.S. regulatory team and oversee compliance for food, drug, and medical product programs under FDA, EU, and other global authorities.

You will drive regulatory strategy, mentor staff, collaborate with R&D, QA, marketing and manufacturing to embed compliance across the product lifecycle, while ensuring timely submissions and risk management. This role requires strong leadership, project management, and excellent communication to

Qualifications

• Bachelor’s degree required.
• 5–10 years in manufacturing, regulatory, EHS roles.
• Experience with FDA and international regulatory requirements.

Responsibilities

• Monitor and interpret evolving regulations for FDA, EU, and global markets.
• Provide regulatory guidance on labeling, packaging, and risk management.
• Direct preparation and submission of regulatory documents (INDs, NDAs, ANDAs).
• Lead regulatory training and cross-functional teams to integrate strategy.
• Manage audits, CAPA, and interactions with regulatory agencies.

Skills

Regulatory leadership

Project management

Cross-functional collaboration

Communication

Education

Bachelor’s degree

Tools

SAP

Job description

Job Description

The Regulatory Manager will be accountable for leading the U.S. regulatory team 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.

The Regulatory Manager will be accountable for leading the U.S. regulatory team 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.

Responsibilities

Regulatory Strategy, Compliance & Guidance:

• 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 a 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.

Regulatory Submissions And Approvals

• 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.

Product Lifecycle Regulatory Leadership

• 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.

Risk Management And Regulatory Audits

• 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).

Cross-Functional Leadership And Regulatory Training

• Lead, coach, and develop the U.S. regulatory team, establishing priorities, strengthening capabilities, and ensuring consistent execution of regulatory strategies and compliance responsibilities.
• 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.

Post-Market Surveillance And Compliance

• 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.

Qualifications

Education and Experience

• Bachelor’s degree
• 5-10 years in manufacturing, regulatory, environmental health and safety

Additional Qualifications

• Proficiency in SAP preferred
• Excellent working knowledge of various computer software applications (i.e., Microsoft Office applications)
• Excellent verbal and written communication skills
• Excellent interpersonal skills; must be able to interface effectively at all levels of the organization
• Project management
• Effective listening skills
• Conflict resolution skills
• Strong organization skills and proven ability to manage multiple priorities and tasks
• Results oriented
• Effective analytical and problem-solving skills
• Strong team player
• Personal ethics and integrity

Physical Demands

The characteristics listed below are representative of the physical and environmental demands required by an individual to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

• Requires remaining in a stationary position for prolonged periods of time, and frequent communication.
• Must be able to traverse and operate computer and other office equipment.
• Typical work is in an office environment where the noise level is low to moderate.

Environmental, Health, Safety, & Security (EHS&S) Requirements

Avient integrates EHS&S into all aspects of our operations. Each position at Avient is responsible for complying with all applicable EHS&S requirements. Additionally, employees and management are responsible for reporting all EHS&S incidents immediately to ensure we keep EHS&S a priority within the organization.

About Us

Our purpose at Avient Corporation is to be an innovator of materials solutions that help our customers succeed, while enabling a sustainable world.

Innovation goes far beyond materials science; it’s powered by the passion, creativity, and diverse expertise of 9,000 professionals worldwide. Whether you’re a finance wizard, a tech enthusiast, an operational powerhouse, an HR changemaker, or a trailblazer in materials development, you’ll find your place at Avient.

Join our global team and help shape the future with sustainable solutions that transform possibilities into realities. Your unique perspective could be the key to our next breakthrough!

We believe that all of our global employees are leaders and that the six most important behaviors for driving our strategy and culture are the same no matter if an employee is a leader of self, a leader of others, or a leader of the business.

By playing to win, acting customer centric, driving innovation and profitable growth, collaborating seamlessly across Avient, and motivating and inspiring and developing others and yourself you will accelerate your ability to achieve Avient’s strategic goals, to meet our customer needs, and to accomplish your career goals.

At Avient, we believe a wide variety of thoughts, ideas and backgrounds gives us the creativity to be successful in a rapidly changing world. In support of this, we stress equality of opportunity for all qualified individuals in accordance with applicable laws. Decisions on hiring, promotion, development, compensation or advancement are based solely on a person’s qualifications, abilities, experience and performance.

Avient is an equal opportunity employer. We maintain a policy of non-discrimination in providing equal employment to all qualified employees and candidates regardless of race, sex, sexual orientation, gender identity, age, color, religion, national origin, disability, genetic information, protected veteran’s status, or other legally protected classification in accordance with applicable federal, state and local law. If you need an accommodation because of a disability to complete an online application, please contact the Avient HR Team by emailing, [e-mail] .