Regulatory Affairs Labelling

As a Regulatory Affairs Labeling Specialist at Viraaj HR Solutions, you will play a crucial role in ensuring compliance and accuracy in product labeling. Your responsibilities will include: - Prepare, review, and maintain accurate labeling submissions for regulatory authorities. - Ensure compliance with global labeling regulations and guidelines. - Collaborate with cross-functional teams to gather necessary information for labeling updates. - Analyze changes in product labels and implement necessary adjustments according to regulatory requirements. - Develop and maintain labeling documentation, including Technical Files and product packaging. - Consistently monitor and ensure adherence to timelines for documentation and submission processes. - Conduct labeling audits and track labeling projects progress. - Address and resolve labeling inquiries and issues raised by regulatory bodies. - Engage in continuous improvement initiatives to streamline labeling processes. - Execute risk assessments and implement mitigations related to labeling compliance. - Provide training on labeling standards and regulatory requirements to internal teams. - Support product launches with appropriate labeling information and materials. - Maintain up-to-date knowledge of international regulations affecting product labeling. - Review and validate labeling content for accuracy and consistency. - Contribute to the establishment and execution of best practices in labeling procedures. Qualifications: - Bachelor's degree in B.Pharma/M.Pharma in Life Sciences or related field. - Minimum of 4 to 6 years of experience in regulatory affairs, specifically in labeling. - Strong understanding of regulatory requirements for product labeling. - Experience in working with international labeling regulations. - Excellent verbal and written communication skills. - Proficient in technical writing and documentation. - Ability to analyze complex information and make sound decisions. - Demonstrated attention to detail in document preparation and review. - Strong problem-solving skills with a proactive approach. - Experience in project management and ability to meet tight deadlines. - Ability to collaborate effectively with diverse teams. - Familiarity with labeling software and regulatory submission tools. - Desirable: Certification in Regulatory Affairs (RAC) or equivalent. - Desirable: Knowledge of clinical trials and medical devices. - Desirable: Experience in a multicultural environment. As a Regulatory Affairs Labeling Specialist at Viraaj HR Solutions, you will play a crucial role in ensuring compliance and accuracy in product labeling. Your responsibilities will include: - Prepare, review, and maintain accurate labeling submissions for regulatory authorities. - Ensure compliance with global labeling regulations and guidelines. - Collaborate with cross-functional teams to gather necessary information for labeling updates. - Analyze changes in product labels and implement necessary adjustments according to regulatory requirements. - Develop and maintain labeling documentation, including Technical Files and product packaging. - Consistently monitor and ensure adherence to timelines for documentation and submission processes. - Conduct labeling audits and track labeling projects progress. - Address and resolve labeling inquiries and issues raised by regulatory bodies. - Engage in continuous improvement initiatives to streamline labeling processes. - Execute risk assessments and implement mitigations related to labeling compliance. - Provide training on labeling standards and regulatory requirements to internal teams. - Support product launches with appropriate labeling information and materials. - Maintain up-to-date knowledge of international regulations affecting product labeling. - Review and validate labeling content for accuracy and consistency. - Contribute to the establishment and execution of best practices in labeling procedures. Qualifications: - Bachelor's degree in B.Pharma/M.Pharma in Life Sciences or related field. - Minimum of 4 to 6 years of experience in regulatory affairs, specifically in labeling. - Strong understanding of regulatory requirements for product labeling. - Experience in working with international labeling regulations. - Excellent verbal and written communication skills. - Proficient in technical writing and documentation. - Ability to analyze complex information and make sound decisions. - Demonstrated attention to detail in document preparation and review. - Strong problem-solving skills with a proactive approach. - Experience in project management and ability to meet tight deadlines. - Ability to collaborate effectively with diverse teams. - Familiarity with labeling software and regulatory submission tools. - Desirable: Certification in Regulatory Affairs (RAC) or equivalent. - Desirable: Knowledge of clinical trials and medical devices. - Desirable: Experience in a multicultural environment.