Manager Regulatory Operations

Our client is a global contract development and manufacturing partner for beauty, personal care and healthcare brands. They develop and manufacture some of the world’s greatest products for global CPGs, emerging brands. Overview Establish and maintain clients regulatory operations program, including establishment of procedures for handling FDA product listings for cosmetics under the MoCRA legislation, OTC pharmaceutical and medical device products and other listings as required by regulators in the markets that we serve. Ensure all registrations and listings are completed and maintained as current, including: Annual FDA Establishment Registration - Cosmetic, OTC and Medical Device FDA Cosmetic Product Listings FDA Medical Device Product Listings FDA OTC NDC Product listings FDA Annual Volume reporting State Licenses Monitor the regulatory landscape and ensure that site management is provided with current regulatory assessments of existing and emerging regulations, ensure that compliance risks are communicated in a timely manner, and develop action plans to address any changes that impact the quality system. Establish and maintain a process for managing customer Regulatory and Compliance related tasks. Responsible for managing customer Regulatory and Compliance related tasks, including: Assist customers in the completion of documentation that supports global product registrations. Supply CDMO documentation to customers that supports global product registrations Review and completion of Quality Agreements to ensure a consistent approach across the client’s portfolio. Requirements BA/BS in relative scientific or technical discipline field Preferred area of study: Science or engineering, biological sciences Experience in a cGMP environment and related Quality field, 3-8 years Certification such as Certified Quality Auditor or Regulatory Affairs Certificate preferred Knowledge of relevant GMP regulations: FDA 21 CFR 210, 211,1, ICH 13485, 21CFR820, familiarity with FDA procedures and MoCRA legislation. Strong focus on continuous improvement and quality, willing to work with others in a fast-paced environment, conscious of the need to implement improvements as a team Strong interpersonal communication, ability to write in a clear, concise manner Travel Occasional travel between clients local sites Education And/or Experience BA/BS Degree in relative science or technical discipline field, preferably Science or Engineering. Experience in a cGMP environment and related QA or Regulatory field, 3-8 years. The client offers a competitive salary package that is dependent on qualifications and experience, as well as a strong benefit package, plus participation in a company-wide bonus plan. Please note that all candidates applying must be a US Citizen or Permanent Resident. Client will NOT sponsor. #J-18808-Ljbffr Scientific Search