Senior Regulatory Affairs Specialist 1

 

 

At our site in Ann Arbor, we are currently looking for a ​Senior Regulatory Affairs Specialist 1​ to be a part of our growing team.

 

 

This position is responsible for leading regulatory product compliance reviews and product safety reviews for Wacker products and raw materials. The Senior Regulatory Affairs Specialist will be responsible for regulatory affairs reviews of Wacker products and data submissions to governmental and nongovernmental agencies. The position is also responsible for  hazard evaluation and classification for finished goods and incoming raw materials according to OSHA Hazard Communication guidelines. The Senior Regulatory Affairs Specialist must also have experience in EPA TSCA and FIFRA regulations and Canadian New Substance regulations. The Senior Regulatory Affairs Specialist will evaluate and respond to incoming internal and external customer product compliance requests and will also perform regulatory reviews of Wacker product formulas and incoming chemicals and provide training on regulatory affairs and product safety to Wacker team members.

 

Job Responsibilities

 

OSHA Hazard Communication and Safety Compliance:

• Responsible for day-to-day departmental functions supporting Wacker US business divisions to ensure health and safety regulatory compliance and product regulatory compliance.
• Activities include chemical hazard review and hazard classification. Provide technical support for internal and external audits per ISO and  ANSI standards. Communicate regulatory updates to Wacker business colleagues.
• Assist Wacker US sites in compliance with OSHA requirements and needed support with workplace exposure.
• Proficient in performing OSHA chemical hazard classification per Globally Harmonized System of Classification and Labeling (GHS) guidelines and communicating that information within Wacker.  Corporate training lead and mentor for GHS and OSHA guidelines.

EPA and Canadian regulatory compliance

• Demonstrate working knowledge of TSCA and FIFRA regulations. Prepare submissions for EPA TSCA Pre-Manufacture Notices (PMNs), Low Volume Exemptions (LVEs), and Polymer Exemptions.
• Prepare New Substance Notifications (NSNs) for Canadian Domestic Substances Listing (DSL).
• Evaluate biocides under EPA FIFRA and Canadian PMRA regulations for suitability to use based on Wacker product application. Evaluate inert ingredients under FIFRA regulations used in Wacker products.
• Submit product formulations for inert review by EPA for US sold products.

SAP compliance:

• Strong knowledge of SAP or equivalent system experience and interpretation of data. Review and provide technical support in authoring Wacker Safety Data Sheets (SDSs) and GHS labeling in SAP. Demonstrate SAP proficiency for search and reporting on various EHS related material issues.

Other regulatory and 3rd party submissions:

• Prepare IMDS automotive submissions for Wacker products. Prepare NSF International product submissions. Assist other departments in response to product safety and product regulatory compliance questions. Knowledge in  Harmonized Tariff Code product classification (HTS).

Document Control:

• Maintain records of EPA and Canadian regulatory submissions. This includes 3rd party submissions as listed above.

 

Job Qualifications

 

• Bachelor of Science Degree in Biology, Chemistry, or Toxicology. Master's Degree preferred.
• 7+ years of relevant experience in the chemical industry or regulatory agency.
• Strong organizational and professional skills with extensive knowledge of TSCA regulations, OSHA Hazard Communication regulation, Globally Harmonized System of Classification and Labeling  (GHS) expertise and reading and interpreting legal documents.
• Knowledge and experience in FIFRA inert requirements and treated article.
• Knowledge of  EPA TSCA regulations and Canadian New Substance Regulati