Rucha Iyer Email & Phone Number

Ahmedabad, Gujarat, India

Mumbai, Maharashtra, India

• Responsibilities:
• Execution of project regulatory strategy as per the standard process for Renewals and evaluation of supporting documentation to confirm acceptability.
• Responsible for communication with the internal & external client sites for Site requests as per renewal requirements and review of documents received from site.
• Collaborate with Client external partners to support compliant execution of renewal management and conduct all activities with focus on regulatory conformance.
• Responsible for handling Response to Queries (RTQ) and Additional Supportive Documentation (ASD) received from the agency and its response preparations.

Mumbai, Maharashtra, India

• Responsibilities:
• Evaluation of various types of change controls (API, BMR, BPR, FPS) for ROW market.
• Liaising with regional team and manufacturing unit to gather the documents and information for timelysubmission/ closure of the change control.
• Compilation of variation package for ROW countries.

Mahim

• Responsibilities:
• Gathering data of rare genetic disorder and to analyze effect of this NUDT15 C415T variant on the Indian Cohort with Patients suffering from acute lymphoblastic leukemia.
• Observing results based on findings planned on a larger Indian cohort, at an International level.

Master'S Degree, Biotechnology, A

Trainings & Workshops attend: • Participated in PCR Analysis and Primer Design training • Concept of Prior Art and Patent Filing •.

Bachelor'S Degree, Biotechnology, A

Activities and Societies: Professional Courses: • Food & Nutrition course from IGNOU • Rio+22 - Unsustainable Energy for All India Program.