Walaa Fawzy Abdel-Hamid

Regulatory affairs supervisorFull Time

• Job Details:• Provide responses to regulatory agencies regarding product information or issues. • Train staff in regulatory policies or procedures. • Coordinate internal discoveries and depositions with legal department staff. • Develop and maintain standard operating procedures or local working practices. • Establish regulatory priorities or budgets and allocate resources and workloads. • Maintain current knowledge of relevant regulations, including proposed and final rules. • Manage activities such as audits, regulatory agency inspections, or product recalls. • Participate in the development or implementation of clinical trial protocols. • Direct the preparation and submission of regulatory agency applications, reports, or correspondence. • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. • Develop regulatory strategies and implementation plans for the preparation and submission of new products. • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. • Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats. • Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives. • Monitor regulatory affairs trends that are related to environmental issues.

Senior Regulatory affair SpecialistFull Time

• Job Details:• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy • Timely compile materials for license renewals, updates and registrations • Maintain regulatory files/database and chronologies in good order. • Establish and maintain system for tracking changes in documents submitted to agencies or partners • Review labelling and labels for compliance with regulatory requirements • Review changes to existing products and SOPs to define the requirements for regulatory submissions • Provide the regulatory reviews of customer complaints and define the regulatory reportability • Responsible for timely registration of the facility • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products • Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process. • Complete submissions to FDA, EU regulatory entities. • Create and maintain product EU technical files. • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws. • Supervise Regulatory Affairs consultants as required

Senior Regulatory affair SpecialistFull Time

• Job Details:• Identify and interpret relevant regulatory guidelines • understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. • Provide technical review of data or reports • review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. • advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. In addition, determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes • Explain regulations, policies, or procedures • Maintain data in information systems or databases • Evaluate applicable laws and regulations to determine impact on company activities • Coordinate regulatory documentation activities