Sakaar Rajput Email & Phone Number

Dandeli, Ka, In

India

I am currently working with Lupin Pharmaceuticals, specializing in eCTD (electronic Common Technical Document) submissions across several global markets, including Europe, Australia, New Zealand, and Canada. With a strong background in regulatory affairs, I handle end-to-end submissions, Variation filings, and respond to complex queries to ensure timely approvals.My key responsibilities include:eCTD Submissions: Leading electronic submissions for new product registrations, post-approval changes, and variations in compliance with regulatory guidelines for multiple countries.Global Market Expertise: Experienced in understanding and aligning submission strategies to the specific regulatory requirements of Europe, Australia, New Zealand, and Canada.Variation Management: Managing and preparing variation submissions, ensuring the incorporation of all necessary amendments to maintain product compliance.Query Handling: Efficiently addressing regulatory authorities’ queries for submission approvals, ensuring a smooth process while maintaining a high standard of compliance and document quality.Cross-functional Collaboration: Partnering with cross-functional teams including R&D, quality, and manufacturing to ensure accurate and complete submission packages.I am passionate about streamlining regulatory processes and am continually staying updated with evolving regulations to ensure compliance across markets. With a keen eye for detail, a solution-oriented mindset, and extensive experience, I aim to support Lupin in delivering high-quality, compliant products globally.

India

With over two years of experience in pharmaceutical regulatory affairs, I specialize in Module 3 validation and stability data review for a diverse range of clients, focusing on both drug substances and drug products. My role involves thorough assessment and documentation of stability studies to ensure compliance with regulatory requirements, including ICH guidelines and regional specifications.I am adept at preparing SFDA templates for the GCC region, aligning submissions with both ICH recommendations and European regulatory standards. My attention to detail and analytical skills enable me to effectively compile and present data that supports the quality and efficacy of pharmaceutical products.Collaborating with cross-functional teams, I ensure that all submissions are accurate, complete, and timely. My familiarity with both international and regional regulations allows me to navigate the complexities of the submission process, facilitating a smoother path to regulatory approval.

Mumbai Area, India

As a Validation Scientist in the Research and Development department, I have been instrumental in supporting the successful validation of various dosage forms, ensuring compliance with regulatory standards and industry best practices. Over the past 3.5 years, I have gained extensive experience working with a wide range of pharmaceutical products, including oral solids, injectables, topical formulations, and more. My role has been critical in ensuring that each dosage form meets the required quality, efficacy, and safety standards before progressing to market.Key responsibilities include:Method Validation: Expertise in developing and validating analytical methods for pharmaceutical products, ensuring consistency, accuracy, precision, and robustness across multiple batches and formulations.Process Validation: Involved in the planning and execution of process validation activities for manufacturing scale-up. Responsible for establishing process parameters and ensuring their control during production to maintain product integrity.Risk Assessment: Conducted detailed risk assessments and gap analyses to identify potential areas of failure in product development and validation stages, ensuring proactive risk mitigation.Regulatory Compliance: Collaborated with cross-functional teams to ensure compliance with regulatory requirements from global health authorities, such as the FDA, EMA, and ICH. Familiar with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).Documentation: Authored and reviewed validation protocols, reports, and Standard Operating Procedures (SOPs) for all R&D activities, ensuring thorough and accurate documentation to support regulatory filings.Equipment Qualification: Led the qualification of analytical instruments and production equipment, including IQ, OQ, and PQ, ensuring they operate within specified ranges for reliable results.

Master Of Science, Industrial Chemistry

Bangur Nagar Degree College, Chemistry

Bangurnagar Degree College Dandeli