Regulatory Affairs Associate

Boston, MA ***** 617-***-****

www.linkedin.com/in/gloria-patel-10 GLORIA PATEL *************@*****.*** EDUCATION:

Northeastern University, Boston, MA Sept 2017 - Present Masters in Science Regulatory Affairs in Drugs, Biologics and Medical Devices ( CGPA-3.54) Related Subjects: Therapeutic Product Development, Human Experimentation, FDA Medical Device Regulation, Global Biotechnology Product Registration: E.U., U.S. Product Regulation. NMIMS University, Mumbai, India June 2013 - July 2017 Bachelors of Pharmacy

Related Subjects: Drug Regulatory Affairs, Intellectual Property Rights, Pharmacopeia Testing & Pharmacovigilance, Pharmaceutical Analytical Approaches.

WORK EXPERIENCE & INTERNSHIPS:

Campus Recreation Cabot- Northeastern University, MA. Sept 2017 - Present

§ Assist Athletic personnel for the purpose of supporting them in the completion of their work activities.

§ Monitors activities and/or projects for the purpose of coordinating activities and ensuring compliance with established administrative requirements.

§ Performs record keeping and general or program specific clerical functions for the purpose of supporting assigned administrator with necessary materials.

Cipla Ltd. R & D Center-Mumbai, India May 2016– June2017 Intern, Formulation ADL Department

§ Handled HPLC, Gas Chromatography, Ultraviolet Spectroscopy and Infrared Spectroscopy.

§ Performed Quality Control test of tablet and capsule formulation.

§ Independently carried out quality control tests on drug products to produce data required for regulatory approval for in clinical development and manufacturing area.

Nanavati Super Speciality Hospital-Mumbai, India. June 2015 – July 2015 Intern, Pharmacovigilance Department

§ Inspection and reporting Medication Error Reports and Prescription auditing.

§ Delivered drugs at the out-patient and in-patient pharmacy.

§ Handled projects like National Accreditation Board for Hospitals & Healthcare Providers. ACADEMIC PROJECTS

• A review article with peer titled “Nanotechnology in Cosmeceuticals” under the guidance of Professor Dr. Amisha Yora, Department of Pharmaceutical Chemistry, where I researched various regulatory aspects of cosmeceuticals and compiled them for review.

• A Pharmacovigilance Program which was organized by the college where we were exposed to monitoring and reporting Adverse Drug Reactions in Dr. R. N. Cooper Municipal General Hospital is a public hospital located in Juhu, Mumbai, India. EXTRACURRICULAR ACTIVITIES

• Preformed communication management as Organizing Committee Member for ‘Kshamta’, social responsibility Forum for year 2014- 2015.

• Organized various Projects for the cultural festival as a part of Committee Member for ‘Isthmus-Urjja,2014-2016’.

• Lead my department as Head of Department of Literally Arts Committee for the year 2015.

• Organized Thalassemia Awareness and Blood Donation Drive as a volunteer as a part of Kshamata SRF of NMIMS.

• Participated as Delegate for Techno-Managerial Skills for Pharmaceutical Industry organized by SVKM’S NMIMS (SPP SPTM) in 2016.

SKILLS

• Computer Skills: MS Office - Word, Excel, PowerPoint, Microsoft Project.

• Regulatory Affairs Skills: Strong knowledge about Code of Federal Regulations, 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, IDE, GCP, GMP, GLP, Scientific misconducts, Sponsors and Investigators responsibilities, IND Process, NDA Process, 510(k) Process, PMA Approval, Device Classifications, Clinical Trial Phases.

• Technical Skills: Performed tasks like Pipetting, centrifuging, aseptic technique, media preparation, cell counts, cell harvesting, cellular protein extraction, managing large amounts of immortal and primary cell lines, operation of a hypoxia chamber, bacterial cell heat fixing, gram staining, acid-fast staining, Bradford-Lowery Protein Assays, SDS-PAGE Gel Electrophoresis, Titrations, Column Chromatography, Western blotting, Radio ligand Competitive Binding Assays, Reverse Transcriptase PCR.

• Soft Skills: Detail Oriented, Highly motivated, energetic, ambitious and hardworking individual.

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