Regulatory Compliance Affairs

SUHAS TANDALE

781-***-**** *******.*@************.*** www.linkedin.com/in/suhas-tandale

EDUCATION

Northeastern University, Boston, MA Dec 2021

Master of Science in Regulatory Affairs

DY Patil University, MH, India Jun 2023

Bachelor of Pharmacy

PROFESSIONAL EXPERIENCE

Regulatory Compliance Specialist Mar 2024 - Aug 2024

Bharat Serums And Vaccines Pvt Ltd

●Assisted in the preparation and submission of global regulatory submissions, including INDs, NDAs, and ANDAs, ensuring timely registration of products in key markets.

●Conducted Regulatory Research and Intelligence activities to keep the division's regulatory strategy aligned with changing global regulations.

●Supported the regulatory team in compliance monitoring by interpreting and implementing guidelines from FDA, EMA, and other global regulatory agencies.

●Helped develop regulatory assessments and strategies for product changes, ensuring minimal disruptions to global registrations

Quality Assurance Intern Jan 2024 – Mar 2024

MEYER Vitabiotics

●Monitored the manufacturing processes of tablets, ensuring adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) as part of regulatory compliance initiatives.

●Supported Post Market Regulatory Reporting by documenting deviations and quality control issues, contributing to safety monitoring and performance evaluation of products released to the market.

●Assisted in preparing for internal and external audits, ensuring regulatory compliance in line with FDA requirements.

Regulatory Affairs and Quality Management Intern Jun 2023 - Oct 2023

ADVY Chemical Pvt Ltd

●Conducted Regulatory Intelligence activities, performing market research and tracking regulatory changes to support the development of robust regulatory strategies for product registrations.

●Supported validation and GMP compliance activities, ensuring that equipment and processes met regulatory and quality requirements.

●Contributed to Corrective and Preventive Action (CAPA) initiatives, providing data and analysis to mitigate quality risks.

●Assisted in audit preparation, helping align organizational processes with FDA standards for regulatory submissions.

Formulation and Analytical Research and Development Intern Jun 2022 - Jul 2022

TEVA Pharmaceuticals

●Developed and optimized pharmaceutical formulations for tablets and capsules, contributing to cross-functional regulatory decision-making by ensuring formulation strategies aligned with regulatory standards.

●Conducted stability and dissolution studies, ensuring product efficacy and compliance with evolving regulations.

●Created and validated analytical methods using HPLC, GC, and UV-Vis spectroscopy, supporting regulatory submissions with scientifically sound data.

●Collaborated closely with R&D and quality teams to ensure compliance with FDA and ICH guidelines, gaining insights into the medical device regulatory landscape

SKILLS AND CERTIFICATIONS

Core competencies

Regulatory Submissions (IND, NDA, ANDA, 510(k)), Knowledge of FDA, EMA, ICH Guidelines, Regulatory Intelligence & Compliance Monitoring, Cross-Functional Collaboration (R&D, Quality, Manufacturing),GMP, GCP, GLP Compliance

eCTD & Dossier Preparation, Risk Assessment & CAPA Management, Post-Market Surveillance & Reporting, Project Management & Regulatory Strategy Development, Global Regulatory Knowledge (US, EU, APAC),Regulatory Audits & Inspection Readiness, Strong Analytical & Documentation Skills

ACADEMIC PROJECTS

Formulation and Evaluation of Luliconazole Antifungal Gel

●Developed and optimized topical antifungal gel formulations of Luliconazole using various concentrations of gel-forming polymers, including Carbopol 934, HPMC, and Delonix Regia gum, resulting in uniform and stable gels with enhanced therapeutic efficacy.

●Performed in-depth assessment of physicochemical properties such as color, odor, pH, and viscosity, ensuring compliance with quality standards. Conducted in vitro drug diffusion studies, successfully determining drug release profiles and extending the formulation's release duration by 15%.

●Ensured regulatory compliance by demonstrating that the Luliconazole gel formulations met industry standards for pH, viscosity, and stability. This led to the creation of a formulation that provides a prolonged release mechanism, offering a more effective solution for fungal infections.

●Authored and published a comprehensive research paper on the formulation, evaluation, and adverse reactions of Luliconazole gel, contributing to the scientific community with findings on in vitro drug diffusion studies and adverse effect evaluations, furthering knowledge in antifungal drug development.

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