Mayur Agrawal

I'm a Regulatory Affairs professional with experience in medical devices, and I'm now looking to transition into the pharmaceutical industry. Alongside my regulatory work, I've also been involved in Formulation R&D and Quality Assurance, which has given me a good understanding of product development, GMP, and quality systems. I've worked on regulatory documentation, submissions, and post-approval activities, and I'm comfortable ensuring compliance and audit readiness.

I'm really interested in applying this combined experience to pharmaceutical regulatory affairs and growing further in this domain.

Sr. Officer- Regulatory Affairs (Indian Market) - Meril Medical Innovations Private Limited - Vapi, Gujarat, India

(2024-04)

• Prepared and submitted DMF, DHF, Test & Import Licenses as per MDR 2017 & CDSCO.
• Led regulatory submissions & strategy for medical devices (DMF, DHF, licenses).
• Managed lifecycle activities (change control, amendments, compliance).
• Ensured audit readiness & documentation control per ISO 13485.
• Collaborated cross-functionally to streamline approvals & timelines.
• Supported post-approval changes (amendments, variations).

Officer- Quality Assurance - Olive Healthcare - Daman, Gujarat, India

(2023-01 - 2023-12)

• Worked on preparing APQR reports to monitor product quality, deviations, complaints, and CAPA effectiveness.
• Managed document control, ensuring proper versioning and compliance with QMS requirements.
• Supported process validation and hold time studies, coordinating with cross-functional teams.
• Maintained accurate documentation to ensure regulatory compliance and audit readiness.

Officer- FR&D - Exemed Pharmaceuticals - Vapi, Gujarat, India

(2021-07 - 2022-10)

• Worked on formulation development of solid oral dosage forms (tablets, capsules), ensuring quality and stability.
• Performed troubleshooting and optimization during trial and pilot batches to achieve desired product performance.
• Handled manufacturing operations like granulation, compression, and coating while following GMP and SOPs.
• Maintained accurate R&D documentation and batch records as per GMP and GDP guidelines.

Master's in Pharmacy - Pharmaceutics - Maharashtra Institute of Technology-WPU, School of Pharmacy, Pune (2021)

Bachelor's in Pharmacy - Maliba Pharmacy of College, Bardoli (2019)

H.S.C - St, Xavier's High School, Vapi (2015)

S.S.C - St, Xavier's High School, Vapi (2013)