Responsibilities Include
- Completion of regulatory submissions, registrations, and required reporting activities. Submit annual reports (CARES Act, EPA, etc) and updates as required
- Provide the regulatory review of product labeling approvals as the QA/RA Department authorization signature, and maintain the NDC directory for the company
- Maintenance of site licenses and registrations to ensure compliance
- Monitors and assesses changes to applicable regulations, guidance documents (ex. FDA compliance guidance), and standards (ex. USP compendia changes), proactively communicates impact and recommendations for compliance
- Works as a responder to client questions and completes client questionnaires, product/company profile information
- Provide regulatory review of customer technical documents (change management activities), including raw material/finished product specifications, artwork, labeling, marketing/promotional materials, etc
- Support new product development and product changes with regulatory guidance and review of marketing materials
- Support the company audit program (internal, supplier, customer, and regulatory) to ensure timely and effective corrective/preventative actions (CAPAs) are developed, implemented, and verified to resolve audit observations, while maintaining compliance with applicable regulations and industry standards
- Creation and maintenance of applicable regulatory dossiers (Drug Master Files, Medical Device Files, Cosmetic Safety Assessments, etc.)
- Lead and enable cross-functional partnerships between Regulatory and key stakeholders at all levels within the company
- Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective system
- This position is also a regulatory support person during customer, certifier, and regulatory audits.
- Perform other duties as assigned
- Bachelor's degree in Life Sciences, Engineering, or a related field, and at least 5 years of relevant experience in the pharmaceutical industry
- Experience with cGMP, FDA, ICH, USP, and EU
- Working knowledge of 21CFR 210 & 211, 21CFR 820, ISO 134875, ISO 9001, Federal and State EPA Regulations
- Regulatory audit experience is a plus
- Working knowledge of Microsoft Word, Outlook, Excel, and Minitab
- Good interpersonal communication skills/able to work in a team environment
- Ability to adapt to changing environments and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
- Knowledge of federal and state EPA regulations
About the company
Company website•Hospitals and Health Care
A Customer-Driven USA Made Brand for Nearly 30 Years.
As a U.S. infection control, first aid & OTC manufacturer, we have been dedicated to leading the fight against preventable infections and cross-contamination for nearly 30 years. Driven by our firm commitment to high-quality products, we manufacture EPA-registered and over-the-counter (OTC) products in our FDA-regulated facility. With our shared vision of protecting people, we offer the very best value in complete product solutions to keep you, your employees, patients, and communities safe.
With over 20 years of experience as a full-service, private label manufacturer, Safetec has developed a team of highly qualified in-house experts to work directly with our customers, ensuring the best products for their brands. With all our services under one roof, we can handle most private label project requests from product ideation through shipping.
Our private label formulations are designed to allow you to be in complete compliance with OTC monograph requirements. From ensuring your labels are compliant to providing a full team of experts to manage and handle your project closely, Safetec is equipped to bring your product from mind to market.
Our growing team of over 150 highly qualified employees will work directly with you to ensure the best production and product delivery. Customers are at the heart of everything we do, and our customers know we are a company they can rely on for high-quality, trusted products. We partner with distributors worldwide to get safe and effective products where they belong, into the hands of those that need them.