Regulatory Specialist

Safetec of America•Buffalo, NY

13d

About The Position

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.

Requirements

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
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

Nice To Haves

Regulatory audit experience is a plus

Responsibilities

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