Regulatory associate trainee

Sai Siva Prasad Tadiboina

*** ******* ******, *** ***, Harrison, NJ 07029 201-***-**** *****@****.***

EDUCATION :

New Jersey Institute of Technology, NJ

Master’s in Pharmaceutical Systems Management (GPA: 3.83/4.0) January 2012 –May 2013

SRM College of Pharmacy, Tamilnadu

Bachelors in Pharmacy May 2011

WORK EXPERIENCE :

Professional Experience (August 2011 - January 2012 )

Hetero Pharmaceuticals ( Jun 2011-Dec 2011) : Regulatory Associate Trainee

Responsible: Regulatory submissions are satisfactory, process are followed and all technical

regulatory requirements are met.

Have undergone Training in Preparing ANDA, Drug Master Files and V-model of Validation by

integrating Facility Requirements

ANDAs, NDAs, INDs, DMFs, annual reports and safety reports

Have Designed Work Break Down structure by using MS Project

Teaching Assistant:

Project Management (Pharmaceutical Systems Management), NJIT:

Responsible for course design, preparation, teaching, evaluation, and grading, assist in conducting

increased learning experience for students in assigned area, Help teacher in a variety of non-

instructional duties, Tutor students independently or in small groups.

Volunteer Experience:

SRM College of Pharmacy (Research Associate)

Assistant to the Professor and guiding the students on Operating Various analytical Equipment’s.

Spend the year in Preparing Sustainable Release Matrix Tablets under the Guidance of Professor

by fallowing the Regulatory requirements.

Organized Conferences by partnering with the faculty, Student government, clubs etc.

ACADEMIC PROJECTS:

Validation and Regulatory issues in Pharmaceutical Industry:

Creating the Drug Master Files, Filling the IND, ANDA and NDA documents. Followed FDA guidelines

which are useful for Pharmaceutical and Biotechnology Industries. Preparing the documents under the

guidance of the FDA, ICH and SOP regulations. Learning experience about Electronic Common Technical

Document (eCTD) and covered the areas like Administrative, CTD summaries, Quality, Non clinical study

reports and Clinical study reports. Good experience on preparing a documents for to submit the CDER,

CBER etc under the FDA regulations. Excellent Knowledge on cGXP.

Pharmaceutical Packaging Technology:

Developed the Projects on Regulatory issues in Packaging industries. Using the 21CFR regulations under

such conditions like various subparts in 21 CFR 201, 210, 211&314.

System Analysis and Design:

Deals with writing vision and scope document and problem statement, BNF, DFD diagrams, Market

analysis, use case study, software system specification, Process model (Scrum), and project plan.

Project Management:

Collaborated effectively with project, to ensure project deliverables remained on track and aligned with

business goals and expectations, meeting summaries and status reports to ensure effective, ongoing

communications across all team members.

Business Process Innovation:

Administered mapping of basic business processes through business process diagrams in BPMN (Using

Microsoft Visio); utilized key business metrics in order to assess and track process performance.

Pharmaceutical Facility Design:

Integrated the Validation Concepts with the Facility Requirements, Undertook the Responsibilities of

Project Manager and Site engineer in the project which is for Bio and Sterile Manufacturing Unit.

Technical Skills:

Working Knowledge on SAS, ISI toolbox, MS office, Excel, Power Point, MS project etc.

Analytical Equipment’s handling, Packaging & Manufacturing of pharmaceutical products,

Quality control.

ACTIVITIES:

Community Service: Panasonic Extreme Make Over

Organized various National Conferences

AFFILIATIONS – Member of ISPE

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