Regulatory affairs, clinical research, quality and compliance, product

POOJA SANJEEV BHAT

Contact No: 973-***-****

Email: **********@*****.***

EDUCATION

Master of Science in Regulatory Affairs

Northeastern University, Boston Present

Master of Pharmacy in Quality Assurance Techniques University of Pune, India Jun 2013

Bachelor of Pharmacy

University of Pune, India Apr 2010

SUMMARY

I am a responsible, organised and goal-oriented professional with knowledge and experience in Quality and Regulatory field with willingness to learn and adapt to various situations. My ultimate goal is to become a well balanced individual and contribute to the pharmaceutical/biotech and medical device industry!

COMPETENCIES

Familiarity with FDA 21 CFR, cGMP, GLP, GCP, ISO13485 and ICH guidelines

Extensive knowledge of regulatory filings such as IND, NDA, ANDA, BLA, IDE, 510(k) and PMA, required for registration of drugs, biologics and medical devices.

Understanding of eCTD, SPL and other data exchange standards useful for dossier submissions and product labeling

EMPOWER, LIMS, Adobe Acrobat and Microsoft Office tools (Word, Excel, Outlook, PowerPoint, Access)

EXPERIENCE

Johnson & Johnson Private Ltd., Mumbai, India Aug 2013-Jun 2015 Analyst (Quality and Regulatory Operations)

Performed validations of analytical procedures for active pharmaceutical ingredients (API) and preservatives in consumer products such as creams, lotions, gels, sunscreens by HPLC

Complied R & D documents for purpose of sample management and associated data by comprehensive usage of LIMS (Laboratory Information Management Systems)

Operated GSS (Global Specification System) for procurement of all test methods, product specifications and global SOPs

Assisted the Regulatory Affairs department in reviewing of ingredient formula, appropriate product labeling and artwork, registration of consumer products

Participated in team meetings with counterparts from worldwide sites such as North America, Europe and Asia Pacific pertaining to discussion of current projects, updates and other information

Contributed in preparation of promotional literature and consumer product surveys Johnson & Johnson Private Ltd., Mumbai, India Aug 2012-Jan 2013 Intern

Carried out Dissertation work successfully at OTC analytical lab

Presented my work in front of R & D scientists

Evolvus Biotech Pvt. Ltd., Pune, India Oct 2010-Feb 2011 Clinical Research Assistant

Executed literature survey from various clinical trial databases such as clinicaltrial.gov, ICTRP

(International Clinical Trials Registry Platform), EU CTR, Pubmed, Embase in order to aid clinical research

Researched documents essential for clinical study such as Informed Consent, study protocol, patient information diaries and consequent IRB approval

Provided clinical data entry and support in order to assist clinical trial operations Pfizer Limited., Mumbai, India Nov 2008-Dec 2008

Student Intern (Quality and Regulatory Operations)

Observed the manufacturing processes for various formulations

Learning of regulations associated with drug development, formulation and associated documentation

INTERESTS

Reading novels

Swimming

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