Solugen

14549 Minetta St., Houston TX 77035

Position

Regulatory Specialist I

About Solugen:

Solugen, Inc. is a revolutionary technology company seeking to use biology to transform the chemicals industry. Solugen was founded in 2016 and is a post-Series B venture-backed startup company supported by renowned venture capital firms, including Founders Fund, Fifty Years, Refactor, and Y Combinator. Located in Houston, Texas, Solugen is currently scaling up its manufacturing facility to use its chemienzymatic process to manufacture biobased chemistries for water treatment, agriculture, and personal care. Solugen presently has 100+ full-time employees.

Mission

Reporting to the Product Regulatory Manager, this individual will be responsible for implementing and overseeing Solugen's Product Safety and ensure compliance with federal regulatory requirements applicable to Solugen. Solugen is a green chemicals company that engages in the manufacture and blending of aqueous-based chemicals. As a small company, this individual must find, vet, and manage a host of area-specific vendors to keep Solugen compliant and safe. Solugen also operates continuous and batch chemical processing/blending facilities. Therefore, a background in DOT/EPA/OSHA and SDS development is critical.

The Regulatory Specialist's primary responsibilities include overseeing part of the Hazard Communication program by managing both the non-commercial and commercial products SDS and labels using expert judgment. In addition, they will be responsible for knowing the global requirements for shipping products related to SDS and Label to ensure compliance. The Regulatory Specialist will need to use professional judgment to manage complex regulatory challenges having multiple interpretations to meet business needs while adhering to corporate ethical and legal conduct guidelines. They will operate both independently and as part of a team in providing critical, solutions-focused support to our clients in interpreting and delivering necessary information according to product development and other environmental-related clearances. They provide crucial support to the company in environmental compliance planning, environmental permitting, due diligence, and environmental review services. They identify and interpret the statutes and regulations affecting the siting, design, construction, and operation of projects; coordinate with regulatory agencies and environmental consultants; and prepare site certification applications, permit applications, and environmental reports.

The role will also require a working knowledge of the applicable rules, regulations, and policies of critical jurisdictional agencies such as but not limited to the Environmental Protection Agency (EPA), Occupational, Safety and Health Administration (OSHA), U.S. Food and Drug Administration (FDA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Department of Homeland Security (DHS), Toxic Substances Control Act (TSCA), etc.

This position will be in Houston, Texas.

Key Outcomes:

  • Develop a Management of Change (MOC) for communicating updated labels and SDS to the Commercial Team and Customers within the first six months of hire.
  • Develop a standard operating procedure for Hazard Communication and Transportation Classification within the first 12 months of hire.
  • Provide backup support to the Product Regulatory Manager as needed
  • Act independently to identify and resolve problems by applying advanced knowledge of Global Hazard Standards and Transportation Rules.
  • Assess proposed regulations and communicate requirements to key stakeholders.
  • Provide regulatory support during internal and external audits.

Qualification and Experience:

  • B.S. or Advances degree in Chemistry
  • Minimum of 3 years experience in SDS authoring and product development
  • Basic knowledge of toxicology and eco-toxicology for chemicals
  • Basic knowledge of exposure assessment
  • Experience in SDS and Labeling Authoring
  • Good working knowledge of OSHA hazard communication
  • Excellent understanding of regulatory standards and laws governing the use of chemicals, as set by Governments/Industries in the various countries.
  • Current Dangerous Goods (DG) multimodal training
  • Experience with HTS and export control classification
  • Organizational and time management skills
  • Computer literacy, particularly of spreadsheet applications
  • Participate in cross-functional teams with minimal supervision
  • Working knowledge of FDA, OSHA, FIFRA, DOT, TSCA
  • Ability to research and interpret regulations
  • Able to handle multiple work interruptions and manage multiple complex projects simultaneously
  • Strong interpersonal and communication skills (oral and written)

Roles/Responsibilities defined

  • Provides Environmental/Health/Safety (EH&S) expertise and coordinates input to new chemical product development.
  • Maintains and interprets chemical supplier's composition data for hazard assessments.
  • Developing and maintaining knowledge of hazard communication requirements.
  • Coordinate data management for hazard assessments and classification criteria to support new and existing products.
  • Review and analyze product physical and health hazard testing as provided by clients necessary for proper hazardous classification.
  • Work within cross-functional teams to develop solutions for the management and improvement of the SDS authoring process.
  • Act as point of contact for customer statements and questionnaires. Manage completion from various groups throughout the value chain.
  • Support import and export activities as needed
  • Assist in developing and managing procedures and systems to perform regulatory operational activities.
  • Assist in gathering supplier raw material questionnaires.
  • Assist in new plant license and certification and maintain renewals as needed (DEA, DHS, EPA, FDA, etc.)
  • Assist in product-specific certifications for markets (CleanGredients, OMRI, COSMOS, etc.)
  • Assist in customer, governmental agency, and certification audits.