5.0 - 7.0 years

0 Lacs

thane, maharashtra, india

On-site

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....

Posted 1 week ago

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Deputy Manager / Manager - Regulatory Affairs - (Derma) Alembic Pharmaceuticals

12.0 - 15.0 years

16 - 20 Lacs

hyderabad

Work from Office

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-...

Posted 2 weeks ago

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Sr. Manager - FRD Non-Orals SUN PHARMA

14.0 - 18.0 years

0 Lacs

vadodara, gujarat

On-site

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...

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Research Associate - Formulations R&D Aragen Life Sciences

1.0 - 5.0 years

0 Lacs

hyderabad, telangana

On-site

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...

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