Project Management

RIA CHHABRA

linkedin.com/in/ria-chhabra/ 518-***-**** *******.*@*****.***.*** Boston, MA

EDUCATION

Master’s in Project Management Northeastern University Boston, MA GPA: 3.6 Apr 2019 Course: Therapeutic Drug Development, Regulatory Affairs foundation for Drugs and Biologics, Human Experimentation, Global Project Management, Change control and Risk Management Bachelor’s in Pharmacy School of Pharmacy, DAVV Indore, India GPA: 3.2 Apr 2016 Course: Biopharmaceutics, Pharmacokinetics, Pharmaceutical Industrial Management, Pharmacy practices in Clinical Trials, Pharmaceutics, Dosage form

SKILL SET

Tools and Technologies: Sharepoint, Visio, Ms Project, Ms Office, Wordpress Project management skills: Work Break down structure, RACI matrix, EVM methodology, Publishing tools: eCTD Express, epublisher

Regulatory Knowledge: ICH guidelines, Regulatory Guidance, Common Technical Document Preparation, Good Manufacturing Practices, Good Clinical Practices, Standard Operating Procedures, Form 510(k) Functional skills: Problem-solving, Organized, Multi-Tasking, Good Written and Oral communication skills PROFESSIONAL EXPERINECE

Regulatory Affair Intern McW Healthcare Indore, India Dec 2016 – Mar 2017

• Communicated and liaised with various departments to conduct training and ensuring compliance with SOP’s and Regulatory Guidance.

• Managed Drug Master File Project registration and shipment to a Nigerian company under strict time constraints

• Used publishing tools like e-publisher to ensure document compliance before submissions to Regulatory authorities

• Led successful team project in direct regulatory authority audit support and preparation Quality Control Intern Riemann labs Indore, India Jun 2015 – Jul 2015

• Assisted in drafting performance qualification protocols for different stages of production

• Performed qualitative studies on product batch and ensuring compliance with GMP and FDA regulation Assistant Pharmacist Greater Kailash Hospital Indore, India Apr 2014– Aug 2014

• Implemented prompt stock inventory system ensuring 100% availability of stock on floor

• Effectively managed customer enquiries related to over-the-counter and prescription medication ACADEMIC PROJECTS

NDA consulting:

• Conducted extensive research to draft a New Drug Application for a firm which has maintained its IND for 10 years

• Suggested the means for getting application approved and the assisted with changes in post-market review

• Applied CTD module for compiling and organizing data

• Developed an understanding of the forms required in the process like Form 356 h, 3397, 3331 IND consulting:

• Recommendations on the Type of meeting for Pre-IND meeting

• Conducted research on the documents required to file for Investigational New Drug Application PDUFA:

• Conducted extensive research on the need for PDUFA in Pharmaceutical industry

• Understood the timelines involved in the process of IND and NDA submissions

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