Qualification: MD in Ayurveda Experience: 10-15 years in handling New Product Design from a reputed Herbal/Nutraceutical R&D Job responsibilities: Identification and selection of traditional herbal ingredients and formulations for product development. Establishing a scientific rationale for formulation design along with supporting claims. Designing preclinical study protocols in collaboration with Contract Research Organizations (CROs). Developing clinical study protocols in consultation with CROs. Conducting periodic reviews of preclinical and clinical study progress in coordination with CROs. Drafting patent documents with detailed claims and liaising with patent attorneys for filing in India and internationally. Drafting research papers and publishing them to high-impact scientific journals. Collaborating with research institutions on projects related to process optimization and method development. Identification and evaluation of innovative ingredients from various vendors for NPDs
Job Description: Department: Formulation R&D Experience: 3 - 7 Yrs. Qualification: M.Sc / M.Pharma Skills: Should have prior experience and knowledge of development of Soft Gelatin Capsules Technical Documentations - BOM / MFR stability study guidelines , QMS knowledge of pharmaceutical development Technology Transfer to commercial site Should have knowledge of development of other dosage forms (Solid Orals / Liquids /Semi-solids) Good to have knowledge on Nutra / Ayurvedic Regulations
Role & responsibilities Handling of Analytical Method validation of Assay and dissolution as per ICH Guidelines. Responsible for the Analysis of Finished products as per STP. Responsible for the Qualification and Maintenance of Working Standards. Responsible for sending of samples to external laboratory and receiving of reports. Maintenance of records / documents for external laboratory services. Dissolution: Carrying out different Media study with compilation of results. Regular Stability Analysis: Well versed with handling of regular Stability samples analysis. Operation and regular maintenance of stability chambers. Documentation: Good knowledge on GLP, GDP, CGMP and maintenance of records, usage logbooks. Preparation of Standard testing procedure for API, In process and finished products, Responsible for report preparation after completion of the analysis. Responsible for generating COAs for working standards and finished products. Responsible for Protocol based studies. OPERATION AND CALIBRATION OF THE FOLLOWING INSTRUMENTS: Knowledge on HPLC with Empower 2 and 3 Software. (UV/PDA) Knowledge on UV-Visible Spectrometer. Knowledge on Dissolution Tester. Knowledge on Operation and Maintenance NOTE: Immediate joiners pereferable
We are seeking a highly skilled and detail-oriented Regulatory Affairs Executive / Senior Executive to join our dynamic team. The ideal candidate will have hands-on experience in applying for and managing regulatory licenses required for the import of raw materials and manufacturing of pharmaceutical, nutraceutical, and Ayurveda products. The role demands expertise in navigating Indian regulatory frameworks, including CDSCO, FSSAI, AYUSH , and obtaining Dual NOCs , Import Licenses , and product registrations . Key Responsibilities: Import Licensing & Raw Material Compliance Apply for and manage raw material import licenses through CDSCO or other relevant bodies. Coordinate with suppliers, freight forwarders, and customs for clearance of imported goods. Ensure compliance with DGFT , customs , and drug control authorities regarding import activities. Dual NOC Applications Prepare and submit documentation for obtaining Dual NOC (Food & Drug Authority) approvals. Liaise with both FSSAI and CDSCO for smooth and timely approvals. CDSCO Regulatory Work Apply for and manage drug manufacturing licenses , test licenses , and formulation registrations under CDSCO. Track changes in regulations and ensure product compliance at all stages. Coordinate with internal QA/QC and R&D teams to ensure regulatory documentation aligns with product specs. FSSAI Licensing Apply for and maintain FSSAI Central and State licenses for nutraceutical and food products. Handle product approvals, label compliance, and liaise with FSSAI officials as required. AYUSH Licensing Coordinate and apply for manufacturing and product licenses under the Ministry of AYUSH . Ensure regulatory compliance specific to Ayurveda, Siddha, and Unani product categories. Documentation & Compliance Maintain updated regulatory files, product dossiers, and tracking logs. Assist in audits and inspections conducted by regulatory authorities. Regularly monitor and communicate changes in relevant regulatory guidelines and policies. Key Requirements: Bachelors or Masters degree in Pharmacy , Life Sciences , or Regulatory Affairs . 3–7 years of hands-on experience in licensing and regulatory documentation in a CDMO or pharma/nutraceutical setup. Strong knowledge of CDSCO , FSSAI , and AYUSH regulations. Experience in applying for import licenses , dual NOCs , and handling regulatory correspondence. Familiarity with SUGAM , FSSAI FoSCoS , Ayush e-Aushadhi portals. Excellent communication and coordination skills. Ability to work independently and handle multiple licensing processes simultaneously.
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