Regulatory Affairs Manager in Tustin, CA at Apex Life Sciences

Date Posted: 2/14/2018

Job Snapshot

Job Description


Growing Nutraceutical Company seeking a Regulatory Affairs Manager to join their team!

DUTIES AND RESPONSIBILITIES:

  • Project management: Manages specific projects focused on improvements, plans and strategies
  • Manages coordination and prioritization of the daily activity of the department and related staff, interacts with various departments as needed on regulatory compliance issues and/or strategies
  • Directs, plans, delegates and manages department budget and staff including staff performance and recommending appropriate actions related to promotion, salary rate and counseling on work related issues.
  • Ensure departments work efficiently to minimize overtime and that established priorities are consistently met
  • Manages, maintains and supports to ensure effective implementation of the following quality systems:

  • REGULATORY AFFAIRS
    • Ensures all areas of direct responsibility are compliant with the Company’s Quality Manual, which includes but not limited to state, federal, and international regulations standards and requirements
    • Ensures compliance relating to product, labeling registration and licensing
    • Approves label/labeling, product disclosures, promotional and advertising materials to ensure regulatory compliance
    • Manages adverse events and advises on medical information related to adverse event reports and consumer inquiries. Interacts with Research and Development, Operations, Logistics, and Quality Control departments to formulate response and resolution of complaints and product issues
    • Oversees quality compliance review and evaluation of material and packaging manufacturers, contract laboratories and recommend supplier qualification/approval
    • Evaluates annual product quality review reports to identify scope for improvement and to verify that the corrective and preventative actions are effective and sustained
    • Oversees and ensures SOPs and company policies are in compliance with regulatory requirements and cGMPs
    • Provides support in both internal and external supplier audits/evaluations to ensure regulatory compliance
    • Communicates with regulatory agencies third party organizations and customer representatives in providing regulatory compliance and capabilities of the company
    • Company representative for CRN – Council for Responsible Nutrition
  • COMPLIANCE
    • Manages, hosts, and ensures proper follow up to external audits (e.g. FDA inspections, Customer audits, Third Party certification audits, NSF, UL, NPA), with the goal to attain the highest adit scores to reduce the frequency of Supplier Audit and corresponding quality costs
    • Obtains licenses and certifications from State and Federal agencies (CDPH, FDA), third party certification bodies (NPA, UL, USP, and NSF); other customer third party inspections and foreign site registrations (Health Canada-Natural and Non-Prescription Health Products Directorate (NNHPD) including product certifications such as NSF certified for Sports, USP Certified Products and Natural Health Product Number (NPN)
    • Responsible for ensuring a safe working environment, compliance to company policies, and Good Manufacturing Practices, Safety, including County Health Care Agency, Environmental Health, SCAQMD and other regulatory related issues
    • Oversees, conducts, and reviews investigations relating to customer complaints, deviations, and product variances, or failure investigations
    • Recommends appropriate process improvements to ensure corrective/preventive actions are implemented for resolution and to prevent recurrence
    • Oversees and schedules internal audit and take lead in the resolution of issues found during audits, this is in conjunction with Quality Assurance and Operations
    • Provides guidance on compliance issues and conflicts acts as a compliance resource
    • Conducts departmental / company-wide trainings on cGMP and other related continuous improvements as required
    •  
  • DOCUMENT CONTROL
    • Develops and improves the Change Control System to ensure all changes are documented, reported and approved in compliance to standard operating requirements of change control process. 
    • Manages document management, maintain and update standard operation procedures accordingly
    • Oversees Document Control functions and responsibilities

Requirements:

  • Master Degree preferred in Life Sciences and 5 years of related experience and/or training; or equivalent combination of education and experience.
  • Minimum 5 years in the dietary supplement/pharmaceutical industry with a minimum of 2 years in Regulatory Compliance.
  • Knowledge of Food and Drug Administration regulations and guidelines including 21CFR.
  • Certification in Quality Systems Audit preferred.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.