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Head of Regulatory Compliance
2 months ago
Summary:
- The Head of Regulatory Compliance is responsible for the formulation, coordination, and execution of regulatory strategies for products necessitating governmental endorsement. This role involves the preparation of marketing submissions essential for securing approval for regulated offerings. The position also entails managing interactions with regulatory bodies and ensuring adherence to compliance protocols.
Key Responsibilities:
- Formulate strategies to guarantee compliance with regulations.
- Oversee the preparation and submission of applications and correspondence to regulatory agencies.
- Evaluate all submission materials to ensure they meet regulatory standards in terms of timeliness, accuracy, and completeness.
- Manage processes related to audits, inspections by regulatory agencies, and product recalls.
- Develop and implement policies and procedures in regulatory affairs to maintain or enhance compliance.
- Prepare Safety Data Sheets and relevant documentation in accordance with DOT regulations.
- Stay updated on pertinent regulations, including proposed and finalized rules.
- Provide regulatory guidance to various departments and ensure accurate interpretation of regulatory information.
- Respond to inquiries from regulatory agencies and clients regarding information or issues related to regulated products.
Required Qualifications:
- Bachelor's degree in Chemistry or Industrial Engineering.
- A minimum of three years of experience in regulatory affairs, including knowledge of FIFRA, Hazardous Material Regulations, Dangerous Goods, and familiarity with international regulations such as REACH-ECHA.
- Comprehensive understanding of regulatory frameworks and a commitment to staying informed about current and emerging regulations.
- Excellent time management capabilities.
- Strong communication skills to effectively inform management and department heads about compliance requirements.
- Proficient in problem-solving and strategic planning to adapt procedures for regulatory compliance.
- Ability to work collaboratively and provide training to team members on regulatory matters.
Physical Requirements:
- Extended periods of sitting and working on a computer.
- Exposure to various chemicals and compounds.
- The physical demands outlined are representative of those required to successfully perform the essential functions of this role. Reasonable accommodations may be made for individuals with disabilities.
Work Environment:
The characteristics of the work environment described are typical for an employee performing the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities. While fulfilling the responsibilities of this role, the employee may encounter fumes, airborne particles, and hazardous or corrosive substances. The noise level in the work environment is generally moderate.
