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Regulatory Affairs Manager
San Fernando, CA

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Konnect Resources

Regulatory Affairs Supervisor

Job Description

Regulatory Affairs Supervisor Konnect Resources San Fernando, CA Job Details Full-time $34 - $38 an hour 1 day ago Qualifications Nutrition Chemical Engineering Master's degree Bachelor's degree Data management Full Job Description Job Overview We are seeking a dynamic and detail-oriented Regulatory Affairs Supervisor to lead our regulatory compliance initiatives to ensure company wide adherence to applicable regulatory requirements. In this pivotal role, you will oversee the development, submission, and management of regulatory documentation. Your expertise will drive compliance across product lifecycle stages, from research and development through manufacturing and post-market surveillance. Join us to influence the regulatory landscape, facilitate successful product approvals, and uphold our commitment to quality and safety. Responsibilities Provide internal regulatory support and compliance guidance regarding company products and their intended use Evaluate supplier documentation and provide guidance to internal staff when information is incomplete or requires clarification Maintain the integrity of the company's raw material substantiation database by reviewing, interpreting, and validating supplier and material information Manage the process of foreign language label creation and coordinate reviews and approvals with applicable third-party organizations Submit products for applicable third-party certifications, including Kosher, Halal, and Organic, and participate in certification audits as required Review and approve regulatory information documents prepared by department staff and serve as a backup for document generation as needed Prepare and submit product formula filings to the TTB Review regulations and supplier documentation to determine international compliance requirements for raw materials and maintain accurate records within the company's compliance database Verify international compliance data entered by Regulatory Affairs Specialists to ensure the accuracy and integrity of the company's compliance database Ensure compliance with FDA regulations, ICH guidelines, ISO 13485 standards, and other relevant health regulation policies. Oversee regulatory strategies for clinical trials, including documentation requirements and approval processes. Manage regulatory compliance projects across multiple teams, coordinating efforts to meet deadlines and quality standards. Conduct thorough regulatory compliance analysis to identify risks and develop mitigation strategies aligned with pharmaceutical regulatory compliance requirements. Maintain current knowledge of and ensure compliance with applicable and emerging regulations, industry standards, and certification requirements, including TTB, IFRA, Kosher, Halal, and Organic programs Apply regulatory expertise to review and interpret requirements related to product labeling, food allergens, genetically modified foods, bioengineered foods, nutrition, organic and religious certifications, FEMA GRAS, FDA, USDA, Proposition 65, and applicable international regulations affecting food ingredients used in manufacturing Ensure bulk product labeling complies with applicable domestic and international regulatory requirements Utilize compliance management software to track documentation status, audit trails, and project milestones effectively. Collaborate with cross-functional teams such as R D, quality assurance, manufacturing, and legal to ensure seamless regulatory processes. Support internal audits and inspections by preparing documentation and facilitating communication with regulators. Drive continuous improvement initiatives in regulatory processes to enhance efficiency and accuracy. Experience Bachelor's or Master's degree in Chemistry, Chemical Engineering, Food Science, or a related field 3-5 years of regulatory affairs experience, including supervisory or leadership experience Experience with Halal, Kosher, or Organic certification processes Ability to interpret and apply global regulatory requirements, standards, and guidance Familiarity with TTB regulations Ability to read, analyze, and interpret professional journals, technical procedures, scientific data, governmental regulations, chemical hazard information, and safety procedures High level of proficiency with Microsoft Office Suite, Outlook, internet applications, and ERP systems Skilled in regulatory compliance management software and data analysis tools for tracking project progress and audit readiness. Excellent writing skills for preparing clear, comprehensive technical documentation and reports. Ability to interpret complex health regulation policies and translate them into actionable plans. Strong project management skills with a track record of leading cross-functional teams on compliance initiatives. Join us as a Regulatory Affairs Supervisor to play a vital role in ensuring our products meet the highest standards of safety, efficacy, and quality! Your expertise will help shape innovative solutions that improve lives worldwide while advancing your career in a fast-paced regulatory environment.
Pay:
$34.00 - $38.00 per hour Expected hours: 40.0 per week Application Question(s): How many years of experience do you have in regulatory affairs, including any supervisory or leadership roles? Do you have experience with Halal, Kosher, or organic certification processes? Do you have experience with international regulations? Are you familiar with TTB regulations? Are you currently authorized to work in the United States? Will you require employer sponsorship for employment authorization now or in the future?
Education:
Bachelor's (Required)
Work Location:
In person