Senior Regulatory Affairs Specialist

At our site in Ann Arbor, we are currently looking for a Senior Regulatory Affairs Specialist 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 Regulations.
• Strong leadership, interpersonal and problem-solving skills. Global communication skills.
• Experience working in cross-functional teams .
• Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
• Strong knowledge and experience working with government agencies.
• Good knowledge of current regulations and new developments pertaining to regulatory affairs.
• Excellent research skills.
• Experience in training and mentoring.
• Excellent listening, written and verbal communication skills, including persuasive skills.

WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.

Be part of our WACKER family, across all nations!

We are looking forward to your online application at www.wacker.com.

Reference Code:23184

#LI-CE1

The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a Green card).

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation,gender identity, marital status, national origin, age, veteran status, disability, or any other protected classes.