7 Anda Submissions Jobs

You will be responsible for the development of new products and optimization of existing formulas in the formulations department. This includes product lines such as solid dosage products (tablets, capsules) and other delivery forms (liquids, powders) for regulated markets like US, Europe, and ROW. Your tasks will involve formulation and process development of oral dosage forms, troubleshooting formula issues, designing and executing formulation trials, and evaluating stability data to finalize composition. It will also be your responsibility to develop manufacturing processes for R&D formulations to ensure successful technical transfer for large-scale batches. Additionally, you will be requ...

We are seeking a highly skilled Formulation R&D professional to lead the development of oral drug delivery systems , primarily focusing on soft gelatin capsules, tablets, and sachets . The role involves driving end-to-end formulation development, process optimization, and technology transfer from lab to commercial scale. The incumbent will be responsible for conceptualizing and executing formulation strategies, troubleshooting technical issues, and ensuring successful product development aligned with regulatory and GMP standards. The position requires close collaboration with cross-functional teams including analytical R&D, manufacturing, and regulatory affairs, while also contributing to in...

As a highly skilled Formulation R&D professional, you will be leading the development of oral drug delivery systems, with a primary focus on soft gelatin capsules, tablets, and sachets. Your role will encompass driving end-to-end formulation development, process optimization, and technology transfer from lab to commercial scale. You will be responsible for conceptualizing and executing formulation strategies, troubleshooting technical issues, and ensuring successful product development in alignment with regulatory and GMP standards. Your collaboration with cross-functional teams including analytical R&D, manufacturing, and regulatory affairs will be crucial for innovation and continuous impr...

Responsible for formulation and process development of Oncology and hormonal products of oral dosage forms (Oral solid and Oral liquid formulations). Troubleshooting and problem-solving of unresolved or new formula issues. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc. Support the manufacturing of exhibit/submission batches per regulatory requirements....

Role & responsibilities Health Canada ANDS (Abbreviated New Drug Submission): Comprehensive knowledge of Health Canada's ANDS pathway for generic drug approvals. Skilled in compiling complete ANDS dossiers (Modules 15) and interpreting regulatory guidance. Experienced in responding to Clarifax and NSNs with scientifically robust justifications. Proficient in eCTD submissions and managing post-approval changes (Level I/II). Drug Master File (API): Expertise in DMF referencing and coordination with API manufacturers for compliant submissions. EU & UK Generic Drug Registration In-depth understanding of EMA centralised, decentralised, and MRP procedures. Skilled in MHRA regulatory pathways post-...

As a seasoned professional in the field of pharmaceutical sciences, you will be responsible for providing technical expertise, strategic leadership, project management, regulatory compliance, and team development in the realm of liposomal drug products. Your primary focus will be on guiding formulation design, optimizing processes, and ensuring adherence to global regulatory requirements for liposomal generics. Utilizing a science-driven approach, you will tackle complex challenges in formulation and manufacturing to drive project success. Leading and managing R&D projects centered on liposomal formulations will be a key aspect of your role, aligning these initiatives with organizational goa...

You will be responsible for the development of new products and optimization of existing formulas across different product lines such as solid dosage products (tablets, capsules) and other delivery forms (liquids, powders) for regulated markets including the US, Europe, and ROW. Your tasks will involve formulation and process development of oral dosage forms, troubleshooting unresolved formula issues, designing formulation trials, and evaluating stability data to finalize composition. Additionally, you will develop manufacturing processes for R&D formulations to ensure successful technical transfer for large-scale batches. In this role, you will write and review various documents such as mas...