Senior Regulatory Affairs Specialist-FDA Food 1

Position Overview:

This position is responsible for managing all data submissions to the US FDA for Food, Food Contact and Cosmetic products, maintain global food facility registrations, provide support for FDA import classifications, as well as reviews of chemical formulations. This position will respond to product compliance requests and be required to utilize available government databases. This role will support Wacker business team members to ensure compliance to FDA, Food Chemicals Codex (FCC), Responsible Care and cosmetic standards and regulations. This position must be able to interpret and ensure compliance to all current and future FDA regulation requirements, must have working knowledge of food safety requirements under Food Safety Modernization Act (FSMA), hold certification as a (PCQI), and have certification in / or willingness to become certified as internal auditor for food and cosmetics.

Job Responsibilities

FDA Food Contact Program Management and Compliance:

• Responsible for managing Wacker's corporate FDA food contact program. Refine current procedures and strategy to accommodate growing business needs. Create and revise Wacker's Food Contact Evaluation letters for customers. Determinations made by reviewing chemical formulas for raw materials and Wacker formulations. Interface with Wacker Quality Management for review and signoff on Good Manufacturing Practices and food contact evaluation letters.
• Interface with 3rd party consultants for Food Contact Notifications. Provide technical support to 3rd party consultants for product notifications.
• Obtain quotes for outside food contact related legal opinions and consultation. Interface with FDA on product submissions, and track progress of their reviews.
• Manage submissions to third party certification organizations such as NSF International. Familiarity with Canadian Food laws and serving as the liaison between Wacker and our Canadian Regulatory Agent.

Corporate FDA Food and Cosmetic Compliance Programs

• Responsible for ensuring Wacker regulatory compliance to FDA food and cosmetic regulations. Work with Corporate Departments to develop processes which ensure ongoing compliance to current FDA regulation requirements under all aspects of Food (including food contact) and cosmetic products produced or offered for sale in US. Maintain working relationship with Divisional Management to ensure compliance knowledge needs are met, as well as provide support and input for International regulatory requirements and external standards including USP-NF, Food Chemical Codex (FCC) where applicable. Familiarity with Canadian Food laws and serving as the liaison between Wacker and our Canadian Regulatory Agent.
• Obtain quotes for outside food contact related legal opinions and consultation. Interface with FDA on product submissions, and track progress of their reviews.
• Maintain and update Wacker's FDA Food facility registrations, as well as serve as interface for other interactions (Export certificates and filings).
• Communicate relevant updates to FDA current and proposed regulations to applicable Wacker departments and divisions.

Divisional FDA Food and Cosmetic Compliance Programs

• Have basic working knowledge of Divisional product groups and end use applications for Wacker products and provide overarching guidance and interface with Divisional and Site Quality Managers and Business Team members to ensure compliance to current and upcoming FDA regulations, International regulatory requirements and external standards including USP-NF, FCC where applicable for each site. Participate in Wacker site internal, Regulatory, and 3rd party compliance audits. Provide support during FDA site inspections.

Document Control:

• Ensure FDA compliance records are organized and maintained.
• Conduct internal compliance review to ensure FDA compliance letters, and supporting information are valid and up to date and reissued within the designated internal review cycle.

Job Qualifications

• Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Food Science. Master's degree is preferred.
• 7+ years' experience
• Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.
• Knowledge and experience in 21 CFR regulations involving GMP, Food Contact, Indirect Food Contact, Cosmetics, FDA Dietary Supplement approval, and GRAS determinations.
• Strong knowledge of 21 CFR Food Additive, Food Contact, Dietary Supplement, and Cosmetic Regulations
• Good knowledge of Generally Recognized As Safe (GRAS) requirements and FSMA, including inspection and audit processes
• Knowledge regarding GMP-Good Mfg. Practices and GDP-Good Documentation Practices.
• Ability to research, learn and properly apply information, such as standards/regulations, without direct supervision.
• Experience working in cross-functional teams.
• Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
• Experience in polymer chemistry is preferred.

#LI-LGI

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  Compensation and Incentive plans
  
  
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  Medical, Dental, and Vision Insurance effective day 1
  
  
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  Paid Time Off in addition to personal days and holidays
  
  
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  Paid parental leave
  
  
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  Wellbeing fund
  
  
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  Flexible hybrid work arrangements
  
  
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  401(k) with company match
  
  
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  Education Assistance Program
  
  
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  Career development and advancement opportunities
  
  
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  Support for Community Involvement