The Senior Regulatory Affairs Specialist at QualiChem is responsible for all regulatory functions associated with QualiChem’s business. This person will provide advice and guidance to the organization on regulatory issues. Specific areas of responsibility include compliance with EPA, DOT, OSHA, and DHS and Export regulations. All activities are performed in the spirit of teamwork and cooperation practiced at QualiChem.
Essential Duties & Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Regular and dependable attendance is an essential function for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties may be assigned.
- Specific Regulatory Functions
- Manage state pesticide sub-registrations and submit annual pesticide report
- Maintain current labels and SDS’s for all pesticide products
- Manage SARA information and submit annual Tier 2 report
- Participate in Local Emergency Planning Committee
- Maintain Spill Prevention Control and Countermeasure Plan and Oil Discharge Contingency Plan
- Manage the hazardous and nonhazardous waste processes
- Submit annual TRI reporting
- Become familiar with 3E SDS and labeling software
- Work with Manufacturing Team to assure that QualiChem conforms to OSHA requirements
- Maintain appropriate records
- Keep safety manual current and update as needed
- Obtain or maintain DOT Hazmat certification
- Organize and schedule Hazmat certification of appropriate QualiChem employees
- Provide regulatory support for domestic and international shipment of products
- REACH and other similar international regulations
- Work with our Only Representatives to assure full compliance
- Maintain records of materials exported to the EU and other countries
- Provide regulatory support for EU distributors of QualiChem products and other international distributors as needed
- Assure QualiChem complies with chemical restriction and control regulations in international countries where we market products.
- Handle all required reporting of volumes, registrations or notifications as applicable.
- Manage our DHS program and perform required audits and ensure continued compliance.
- Export Compliance Program
- Maintain and oversee the Export Compliance Program
- Complete required internal audits
- Review all exports for compliance
- Customer Support
- Provide technical support for regulatory issues that arise as QualiChem products are utilized
- Respond to QualiChem Sales personnel, distributors, and end-users
- Participate in industry trade organizations
- Join the SHERA and MW committee of ILMA
- Participate in appropriate trade organizations
- Oversee the ISO 9001:2015 QMS
- Lead the internal auditing team
- Assure that documents and records are properly stored and maintained
- Maintain the Quality Manual and other necessary documents
- Lead and coordinate IS0 9001 audits with BSI auditors
- Coordinate and lead audits with outside auditors from various regulatory agencies when conducting regulatory audits at QualiChem.
- Conduct New employee training and annual company training
- Assign forklift training, Respiratory medical testing and Security Plan training
- Strong written and oral communication skills
- Must be detail oriented and ability to work independently
- Proven ability to partner with multiple internal departments and external partners to ensure compliance of all local, state, federal and international regulatory requirements
- Knowledge of MS Windows and MS Office Applications
Education and/or Experience:
Bachelors in Regulatory Affairs or related field and 5-10 years’ regulatory experience.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands for picking, pinching, typing or otherwise
working. Specific vision abilities required by this job include close visual acuity to perform an activity such as preparing and analyzing data and figures; viewing a computer and extensive reading.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is low to moderate.
QualiChem is an Equal Employment Opportunity Employer meaning that we make all decisions concerning the terms and conditions of employment, from hiring to firing, to the services and benefits we provide, on a non-discriminatory basis. All such decisions are made without regard to an individual’s race, color, creed, religion, age, sex/gender, national origin, disability, genetic profile or any other status protected by federal and applicable state law.