Senior Regulatory Specialist

The Vincit Group

$75K — $95K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in Chemistry, Biology, Biochemistry, Polymer Science, or Regulatory Affairs required.
  • 5-7 years of experience in regulatory affairs required; 7+ years preferred with US EPA, FIFRA, and FDA authorities.
  • High attention to detail and excellent organizational skills essential.
  • Ability to multitask, problem solve, and adhere to strict deadlines required.
  • Proficient in MS Office applications including Outlook, PowerPoint, Excel, and Word.

Responsibilities

  • Manage product registrations for US, Canada, and Mexico including preparation and submission of documents.
  • Create and execute regulatory strategies to support business objectives.
  • Develop and update Safety Data Sheets (SDS) and product labels.
  • Assess compliance of label modifications and marketing materials to regulations.
  • Maintain product registrations with US EPA and State EPA authorities.
  • Stay informed on current and future regulatory changes relevant to the industry.
  • Collaborate with various departments to ensure compliance standards are met.

Benefits

  • Opportunity to work at the forefront of chemical regulatory compliance.
  • Collaboration with a dynamic team across multiple departments.
  • Room for professional growth within the regulatory affairs field.
  • Exposure to diverse regulatory environments in North America.
  • Access to ongoing training and updated industry knowledge.
Full Job Description
The Senior Regulatory Specialist position plays a key role in ensuring compliance with a variety of regulations within the industry. The Senior Regulatory Specialist is responsible for preparing, amending, and maintaining product registration for all product categories within our chemical manufacturing division and staying up to date with regulatory changes. This role works closely with the Regulatory Affairs and Lab team. JOB SUMMARY: The Senior Regulatory Specialist position plays a key role in ensuring compliance with a variety of regulations within the industry. The Senior Regulatory Specialist is responsible for preparing, amending, and maintaining product registration for all product categories within our chemical manufacturing division and staying up to date with regulatory changes. This role works closely with the Regulatory Affairs and Lab team. EDUCATION: Required: Bachelor’s degree in a related field (Chemistry, Biology, Biochemistry, Polymer Science, Regulatory Affairs, etc.) EXPERIENCE: Required: 5-7 years of experience working in regulatory affairs. Preferred: 7+ years of experience working with US EPA, FIFRA, and FDA authorities regarding new and existing product registrations and label amendments in US, Canada and Mexico. POSITION REQUIREMENT(S): Specialized Skills/License/Certification Required: High attention to detail and organizational skills. Ability to multitask and problem solve, system and process oriented, ability to comprehend federal and state regulations, and effective communication skills. Ability to work independently and adhere to strict deadlines. Knowledge of regulatory requirements pertaining to industrial cleaning chemicals. Proficient in MS Office Applications (Outlook, PowerPoint, Outlook, Excel, Word). Experienced in data collection, analysis, and documentation. Strong understanding of laws and regulations pertaining to chemical regulatory management. CORE COMPETENCIES (Essential Job Functions) 1. Responsible for managing product registrations for US, Canada and Mexico, encompassing preparation and submission of state and federal documents, as well as the upkeep of current registrations and any necessary amendments. 2. Create and execute regulatory strategies aligned with business goals to facilitate the achievement of organizational objectives. 3. Develop and update SDS and labels. 4. Assess regulatory compliance of label modifications and marketing materials. 5. Maintain US EPA and State EPA product registrations. 6. Maintaining knowledge on amended, current and future regulation changes as it relates. 7. Collaborate with multiple departments as needed to ensure compliance. 8. Partner with necessary third-party consultants. 9. Perform other duties as assigned. VIN123

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