Job DescriptionThe 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.
ResponsibilitiesRegulatory 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.
QualificationsEducation 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 DemandsThe 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.
Security includes physical security and cyber security.
