Regulatory Specialist

Safetec of America is seeking a regulatory professional to support and ensure compliance across all product lines and operations. This role is responsible for managing regulatory submissions, product registrations, labeling approvals, and site licenses, while staying current on FDA, EPA, and global regulatory requirements.

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
  
  

Required Skills And Work Experience

• 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