Regulatory Compliance Manager at TUFCO – Green Bay, Wisconsin

Job Overview

We are seeking an experienced and detail-oriented Regulatory Compliance Manager to oversee and ensure adherence to regulatory standards within our organization. The ideal candidate will play a critical role in maintaining compliance with industry regulations, including FDA guidelines, and will support our research, clinical trials, and manufacturing processes. This position offers an opportunity to lead compliance initiatives, collaborate across departments, and uphold the highest quality assurance standards in a dynamic environment focused on innovation and excellence.

Responsibilities

• Develop, implement, and maintain comprehensive compliance programs aligned with industry regulations such as FDA, OSHA, and EPA.
• Monitor ongoing clinical trials and manufacturing activities to ensure regulatory adherence and quality standards.
• Audit and oversee the submission of all regulatory filings and permit applications, verifying that documentation meets strict local, state, and federal standards to mitigate legal and operational risk.
• Lead audits and inspections, preparing documentation and addressing any compliance issues identified.
• Collaborate with Product Development team to ensure that all research activities meet regulatory and quality assurance standards.
• Manage documentation related to chemistry, manufacturing & controls (CMC), ensuring accuracy and completeness.
• Provide training and guidance to staff on compliance policies, procedures, and regulatory updates.
• Stay current with evolving regulations and industry best practices to proactively update internal processes.
• Coordinate with project management teams to integrate compliance requirements into project timelines and deliverables.

Qualifications

• Bachelor’s degree in Chemistry, Life Sciences, or a related field; advanced degrees or certifications in regulatory affairs are preferred.
• Proven experience in compliance management within the pharmaceutical, biotech, or healthcare industries.
• Strong knowledge of FDA regulations, clinical trial processes, and quality assurance standards.
• Experience with research activities, clinical trials oversight, and manufacturing controls.
• Excellent project management skills with the ability to lead cross-functional teams effectively.
• Strong analytical skills with attention to detail for documentation review and process audits.
• Effective communication skills for training staff and liaising with regulatory agencies.
• Demonstrated ability to adapt to changing regulatory landscapes and implement necessary updates efficiently. This role is integral to maintaining our commitment to safety, quality, and regulatory excellence across all operational facets.

Disclaimer:

The above statements are intended to describe the general details of the essential responsibilities being performed in the job. It is not designed to be a comprehensive list of all duties and responsibilities. All associates may be required to perform duties outside their normal responsibilities from time to time, as needed. The company reserves the right to make changes to the job description at any time.