Required 2 to 4 Years of Experience. Required Qualification : B.Sc/ M.Sc Job Description : Product Testing : Raw material , Finish and stability Documenation : As per GMP Instrument Knowledge : GC. HPLC, UV , balance & all instruments calibration Job Types: Full-time, Permanent Pay: ₹300,000.00 - ₹400,000.00 per year Benefits: Health insurance Provident Fund Work Location: In person
Required Qualifications & Skills: Education: A bachelor's degree in Pharmacy (B.Pharm), Pharmaceutical Sciences, Chemistry, diploma in Regulatory Affairs . Experience: 3 to 4 years of experience in a regulatory affairs role within the pharmaceutical or API industry is essential. Familiar with regulatory submission systems . Key Skills: Regulatory Knowledge: A strong and current understanding of global regulatory frameworks, including ICH guidelines, US FDA regulations (e.g., 21 CFR), European regulations (e.g., EudraLex), and regional-specific requirements. Communication Skills: Excellent written and verbal communication skills are necessary for drafting clear and concise regulatory documents, as well as for liaising with regulatory agencies and internal teams. Analytical and Problem-Solving Skills: The ability to analyze complex data, interpret regulations, and devise solutions to regulatory challenges is crucial. Teamwork: The ability to collaborate effectively with different departments to gather the required information for submissions. Key Responsibilities: Dossier Preparation and Submission: Prepare and submit regulatory dossiers for new APIs, renewals, and variations to regulatory agencies (e.g., US FDA, European Medicines Agency (EMA), CDSCO in India, etc.). Compile, review, and manage all relevant documents, including the Chemistry, Manufacturing, and Controls (CMC) section, analytical data, stability studies, and process validation reports. Ensure all submissions are complete, accurate, and meet the specific requirements of each regulatory body. Regulatory Compliance and Strategy: Serve as the primary point of contact and liaison with regulatory authorities. Respond to queries and deficiency letters from agencies in a timely and comprehensive manner. Monitor and interpret new and changing regulations, guidelines, and industry standards to ensure ongoing compliance. Provide strategic advice to cross-functional teams (e.g., R&D, Quality Assurance, Quality Control, and Manufacturing) on regulatory requirements throughout the product lifecycle. Lifecycle Management: Manage and track the lifecycle of API registrations, including renewals, variations, and annual reports. Prepare and submit documentation for changes in the manufacturing process, raw materials, or specifications. Ensure all post-approval commitments are met. Documentation and Record-Keeping: Maintain a robust documentation management system for all regulatory submissions, approvals, and correspondence. Ensure all regulatory files are organized and easily retrievable for inspections and audits. Review and approve product-related documentation, such as labels, packaging inserts, and promotional materials, for regulatory compliance. Audits and Inspections: Facilitate and support regulatory inspections and audits by acting as a company representative. Prepare necessary documentation and information for inspectors. Assist in the development and implementation of corrective and preventive actions (CAPAs) in response to audit findings. Interested candidate share CV to [email protected] Job Types: Full-time, Permanent Pay: ₹400,000.00 per year Benefits: Health insurance Leave encashment Provident Fund Work Location: In person
Required Qualifications & Skills: Education: A bachelor's degree in Pharmacy (B.Pharm), Pharmaceutical Sciences, Chemistry, diploma in Regulatory Affairs . Experience: 3 to 4 years of experience in a regulatory affairs role within the pharmaceutical or API industry is essential. Familiar with regulatory submission systems . Key Skills: Regulatory Knowledge: A strong and current understanding of global regulatory frameworks, including ICH guidelines, US FDA regulations (e.g., 21 CFR), European regulations (e.g., EudraLex), and regional-specific requirements. Communication Skills: Excellent written and verbal communication skills are necessary for drafting clear and concise regulatory documents, as well as for liaising with regulatory agencies and internal teams. Analytical and Problem-Solving Skills: The ability to analyze complex data, interpret regulations, and devise solutions to regulatory challenges is crucial. Teamwork: The ability to collaborate effectively with different departments to gather the required information for submissions. Key Responsibilities: Dossier Preparation and Submission: Prepare and submit regulatory dossiers for new APIs, renewals, and variations to regulatory agencies (e.g., US FDA, European Medicines Agency (EMA), CDSCO in India, etc.). Compile, review, and manage all relevant documents, including the Chemistry, Manufacturing, and Controls (CMC) section, analytical data, stability studies, and process validation reports. Ensure all submissions are complete, accurate, and meet the specific requirements of each regulatory body. Regulatory Compliance and Strategy: Serve as the primary point of contact and liaison with regulatory authorities. Respond to queries and deficiency letters from agencies in a timely and comprehensive manner. Monitor and interpret new and changing regulations, guidelines, and industry standards to ensure ongoing compliance. Provide strategic advice to cross-functional teams (e.g., R&D, Quality Assurance, Quality Control, and Manufacturing) on regulatory requirements throughout the product lifecycle. Lifecycle Management: Manage and track the lifecycle of API registrations, including renewals, variations, and annual reports. Prepare and submit documentation for changes in the manufacturing process, raw materials, or specifications. Ensure all post-approval commitments are met. Documentation and Record-Keeping: Maintain a robust documentation management system for all regulatory submissions, approvals, and correspondence. Ensure all regulatory files are organized and easily retrievable for inspections and audits. Review and approve product-related documentation, such as labels, packaging inserts, and promotional materials, for regulatory compliance. Audits and Inspections: Facilitate and support regulatory inspections and audits by acting as a company representative. Prepare necessary documentation and information for inspectors. Assist in the development and implementation of corrective and preventive actions (CAPAs) in response to audit findings. Interested candidate share CV to hr@ompharmaceutical.com Job Types: Full-time, Permanent Pay: ₹400,000.00 per year Benefits: Health insurance Leave encashment Provident Fund Work Location: In person
As a Safety Officer with 1 to 3 years of experience and a qualification of B.Sc/ Diploma in Safety, you will be responsible for Policy Development and Implementation, Risk Assessment and Hazard Identification, Workplace Inspections, Incident Investigation and Reporting, and Safety Training and Education. Additionally, the company offers benefits including Health insurance and Provident Fund. Please note that this is a Full-time, Permanent position and the work location is in person.,