Swapnil Pawar Email & Phone Number

Mumbai, Mh, In

Mumbai, Maharashtra, India

I spearhead formulation development for solid/liquid pharmaceutical products in EU and UK markets, ensuring compliance with regulatory standards and company protocols while crafting product strategy alongside Quality Target Product Profile (QTPP), identifying critical attributes, and aligning experiments with regulatory and company guidelines. Additionally, I lead discussions and oversee measures for process validation and submission batches at manufacturing sites, ensuring adherence to quality standards, and orchestrating seamless collaboration among stakeholders including regulatory affairs, quality assurance, and procurement to facilitate project execution. Furthermore, I provide technical oversight for projects outsourced to Contract Research Organizations (CROs), offering support as needed, and coordinate technical and techno-commercial support for products manufactured at Contract Manufacturing Organizations (CMOs), ensuring smooth operations.

Mumbai Area, India

I innovated and oversaw the development of solid/liquid/semi-solid pharmaceutical dosage forms for global markets, including the US and EU, while driving product strategy implementation and Quality Target Product Profile (QTPP) alignment, identifying critical attributes, and adhering to regulatory requirements and company standards. Additionally, I formulated and presented proposals for NDDS – ANDA/NDA/SNDA/NCE projects, ensuring compliance with Non-Infringement Strategies in day-to-day operations, and specialized in oncology products, hormones, and complex formulations, contributing expertise to project development. Moreover, I mentored junior team members, guided daily trials, and evaluated experiments to maintain high standards of performance, while strategically planning and executing procurement of RLD samples, Excipients, Packaging materials, Equipment, Change parts, and Spare parts for development and scale-up batches. Furthermore, I ensured seamless implementation of scale-up and exhibit batches, applying risk assessment and mitigation strategies at manufacturing locations, collaborated with regulatory teams for dossier filings and addressed deficiency queries during product reviews by regulatory authorities, providing comprehensive project updates to senior management and stakeholders and implementing effective remedial measures for identified deviations.

Mumbai Area, India

I formulated and executed product strategy in conjunction with the Quality Target Product Profile (QTPP), identifying critical material, quality, and process attributes aligned with business and operational needs while utilizing the Design of Experiments methodology to ensure compliance with current regulatory requirements and adhere to company standards and systems. Additionally, I established solid and semi-solid pharmaceutical products for the US, EU, and global markets, collaborating with regulatory teams for seamless dossier filing and successfully addressing deficiency queries during regulatory product reviews, demonstrating expertise in resolving issues, all while managing formulation projects within project SLA parameters, showcasing efficiency and adherence to timelines and quality standards.

Ahmedabad Area, India

Vadodara Area, India

Mumbai Area, India

B. Pharma, Pharmaceutical Sciences, A+

M Pharm, Pharmaceutics-

M. Pharma, Pharmaceutics, Distinction