Professional Summary:

Dear Recruiter,

I am Seeking a relevant job position in your organization.

I currently hold an M.Sc.-Ph.D. degree in Biotechnology from the Indian Institute of Technology – Bombay (IIT-B), Mumbai, India. 

I am a Self-motivated Regulatory Affairs Specialist holding about 2 years of Pre-clinical research experience within an academic (at IIT-Bombay) setting and having Industrial working experience from 2021. Abroad working experience as Newton-Bhabha Fellow awardee at Loughborough University, United Kingdom. Skilled at preparing regulatory documents for the European Union Medical Device Regulation (EU-MDR), including reviewing materials, technical data, and accuracy of filings. I am fully versed in all aspects of EU MDR regulations and policies regarding all medical devices and understand the guidance that is used for these regulations. I can collaborate and interact with many different disciplinary groups to develop and register marketing strategies for any project.

Articulate and personable with exceptional data analysis, report writing, and record-keeping abilities. Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Proficient in regulations, standards, and best practices. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.

I am able to conduct research for regulatory needs and can allocate the affairs along with submitting advertising proposals and any promotions the client requires. In order to do this, I always keep up with the latest trends and merge all new requirements for each department. I have great communication skills which enable me to offer large or small meetings to ensure that all department heads know and understand these trends.

I am also able to submit annual reports and any control documents that are required by the EU MDR.  In order to do this, I will always make sure that each department submits its data by the timelines that are set.

During my Ph.D. thesis; I developed Nanoformulation for Breast cancer therapy and have done in-vivo studies on a 4t1 mice model. During in-vivo studies; I have developed skills in Pre-clinical research which include: Biocompatibility, Immunology, Cancer Biology, Cell or Molecular biology, and Particle characterization. My Ph.D. thesis work leads to giving 4 patents. Details were given in my CV.

I would enjoy discussing the relevant job positions available in your organization.  If you require any additional materials or information, I am happy to supply that.

I thank you for the valuable time you spent here.