Basic understanding of Clinical pharmacology, pharmacokinetics and toxicological aspects Review of literature and preparation of Biopharmaceutics review, Dissolution studies , Biowaiver/Bio strategy Basic understanding of bioequivalence studies for various regulatory agencies Review of study specific documents for BE studies (like study protocol, ICF,CRF, CSR, TMF) Monitoring & audit of clinical phases of Biostudies and Quality management system Co-ordination with CROs for execution of Pilot and Pivotal bioequivalence studies. Co-ordination with internal departments for BE NOC/TL documents and project contracts/invoices. Management, receipt, logistics and shipment of study IMPs to CRO’s Submission of finalized BE reports to regulatory department for submission and handling of regulatory queries related to module 5. Basic understanding of GCP Guideline and Clinical trials, NDCT Rule etc

Job Responsibilities: Perform pre-formulation studies, R&D trials and support scale-up activities. Conduct R&D trials for oral solid dosage forms (tablets, capsules, etc.). Develop and optimize formulations to meet regulatory and quality requirements. Document and analyze trial data to improve formulations. Collaborate with cross-functional teams for technology transfer to manufacturing. Requirements: M.Pharm or equivalent in Pharmaceutics/Pharmaceutical Sciences. Hands-on experience in formulation development of oral solid dosage forms. Knowledge of QbD, regulatory guidelines, and process optimization. Strong analytical and problem-solving skills.

Key Responsibilities will include : 1) Experience in technical review and compilation of registration dossiers for regulated markets. 2) Review of master documents (Specifications, MFR, BMR, BPR, PVP, PVR, HTSP, HTSR, PDR, elemental impurity risk assessment, nitrosamine risk assessment, stability protocols), DMF. 3) Deficiency management for products filed to regulated markets.

Outlines quality assurance procedures and policies Oversees implementation of quality assurance procedures Ensures the efficiency of inspections through hands-on guidance Ensures data integrity and accuracy Prepares reports on the results of quality inspections Evaluates outcomes of quality inspections and proposes corrective measures. Preferred skills : IPQA, Line clearance, BMR/BPR preparation and & Exposure in review Qualification of equipment and HVAC (DQ, IQ, OQ, PQ) Process validation, Protocol preparation and review Documentation, Change Control, deviation, Market Complaint, CAPA, etc.

Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible to follow all regulatory/cGMP/Statutory/Company policies are followed in manufacturing area. Responsible for online documentation with real time data. Responsible to participate in equipment qualification and process validation activities Preferred skills : Granulation, Compression, coating and packing of & Exposure in OSDs

Staying up to date with international engineering trends. Identifying and addressing problems. Supervising production. Estimating costs and timelines. Conducting research and applying new knowledge. Designing processes, materials, tools, and systems. Making improvements to existing processes, materials, etc. Implementing solutions and designs. Training other engineering personnel Preferred skills : Handling preventive maintenence Exposure in (OSD equipments) Granulation, Compression, Coating and packing equipments, utilities, DG and other electrical aspects.

Must have: Manage and track Advance Authorization Licenses, ensuring timely application, utilization, and compliance to secure export incentives. Liaise effectively with DGFT offices and portals (both online and offline) for matters related to E-com applications, EODC issuance, ECGC, DTEP, EPCG, LUT Bonds, and related schemes. Handle No-Norms/Self-Declaration approvals and maintain compliance with regulatory standards. Oversee license registration processes with Indian Customs, ensuring accurate and timely documentation. Prepare and process ARO (Advance Release Orders) and Invalidation Applications as per export requirements. Apply for and obtain various Certificates of Origin (CoO) from DGFT and other authorized agencies. Ensure accurate documentation for Drawback (DBK) claims and other export incentive schemes under Customs. Prepare and review all pre-shipment and post-shipment documentation to support export operations. Monitor and control shipment costs to ensure they remain within budgeted limits. Maintain and update detailed tracking reports for: Shipment movement Advance License utilization Export incentives and benefit realization ECGC and DGFT compliance Ensure timely application and follow-up for Export Obligation Discharge Certificates (EODC). Coordinate applications for norms fixation and amendments under Advance Authorization schemes. Want to Have: Hands on experience in MS-Excel. Excellent organizational and multitasking abilities with attention to detail. Proficiency in using procurement software and Microsoft Office suite. Good communication skills, both written and verbal. Ability to work collaboratively in a team environment and meet deadlines. Role & responsibilities

Responsible for the development and dossier deliverable of genreic application for projects assigned with in the team for Europe ,Canada Australia. Preparation ,review and approval of test licenses Import license applications. Planning and procurement of RMPMs/ RLDs and inventory control at R&D for development. Preparation and review of RMPMs/Justification of Specifications/Cleaning validation report/Risk assessment report/ stability protocol/CDRs/Technology Transfer dossiers. Review of MFRs/BMRs/BPRs/PVPs/HTS, product specific questionnaire, Protocol; and report etc. for scale up and registration batches Timely and Appropriate Reponses for CMC and Bio deficiencies from regulatory agencies for filed products and review of R&D documents for regulatory and quality audits.

Impurity synthesis, Impurity Characterization COA generation HPLC, LCMS, NMR TGA instrument handling and interpretation

Formulation Development, OSD ,

Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible to follow all regulatory/cGMP/Statutory/Company policies are followed in manufacturing area. Responsible for online documentation with real time data. Responsible to participate in equipment qualification and process validation activities Preferred skills : Granulation, Compression, coating and packing of & Exposure in OSDs