Shreya Shreya
Regulatory Writer
Professional Overview
Shreya Shreya is a seasoned regulatory writer with extensive expertise in the pharmaceutical industry. In her current role, she is responsible for drafting and reviewing regulatory documents, ensuring compliance with industry standards and guidelines. Shreya's proficiency in medical terminology, data analysis, and regulatory best practices enables her to deliver high-quality submissions and effectively communicate complex information to various stakeholders.
Experience Summary
Current Role
Shreya currently serves as a Regulatory Writer at DDReg Pharma Pvt. Ltd., a leading pharmaceutical company. In this role, she is responsible for:
- Drafting and reviewing regulatory documents, including clinical trial protocols, investigator brochures, and New Drug Applications (NDAs)
- Collaborating with cross-functional teams to ensure regulatory submissions are accurate, complete, and compliant with applicable laws and regulations
- Providing strategic guidance on regulatory strategies and optimizing submission processes
- Staying up-to-date with evolving regulatory requirements and industry best practices
Career Progression
Prior to her current role, Shreya worked as a Freelance Regulatory Writer at Innodata Inc., where she contributed to various pharmaceutical projects and honed her skills in regulatory writing and document management.
Academic Background
Shreya holds a Bachelor's degree in Pharmaceutical Sciences from the National Institute of Pharmaceutical Education and Research (NIPER), India. She has demonstrated academic excellence throughout her studies, with a strong focus on regulatory affairs, pharmaceutical chemistry, and drug development.
Areas of Expertise
- Regulatory writing and document preparation
- Pharmaceutical regulatory compliance
- Medical terminology and data analysis
- Collaboration with cross-functional teams
- Continuous learning and adaptation to industry changes
Professional Impact
Shreya's contributions have been instrumental in supporting the successful submission of several regulatory documents, leading to the timely approval of pharmaceutical products. Her attention to detail, strong technical writing skills, and ability to translate complex information into clear and concise narratives have been highly valued by her colleagues and industry partners.
Conclusion
With her extensive regulatory experience, Shreya continues to drive innovative solutions and maintain the highest standards of quality in the pharmaceutical industry. Her dedication to staying at the forefront of regulatory best practices and her commitment to collaborating with cross-functional teams make her a valuable asset to any organization seeking to navigate the complex regulatory landscape.
