The document is a cover letter and resume from Deepthi Kondapalli applying for a position in regulatory affairs. She has over 5 years of experience in regulatory affairs and quality assurance at Aurobindo Pharma Limited. Her experience includes international submissions, audits, variation procedures, and ensuring documentation compliance. She is seeking the position due to the company's leadership, culture of innovation, and challenges of international audits.

1. Deepthi Kondapalli
Mobile: 09030275188, 08712352942
E-Mail: kondapallideepthi@gmail.com
Dear Sir/ Madam,
Please find attached my Resume for the suitable position in Regulatory Affairs with
experience in Regulatory Affairs/Quality Assurance in the Pharma industry.
As Executive-Quality Assurance Department with Aurobindo Pharma Limited,
Visakhapatnam, I believe I meet all the essential criteria of the position. Highlights of
experience and demonstrated talent I would bring to your organisation include:
o A keen communicator with honed interpersonal, problem solving and analytical abilities.
I am keen to join your firm due to its leading position in the industry, great organizational
culture, spirit of innovation, professionalism (you can choose as you see fit) that
characterizes your firm and its employees. I am attracted to this role on account of the
broadening of my knowledge, challenges involved, to face the international audits that it
offers.
I appreciate your taking the time to review my credentials and experience. Looking forward
to a positive response.
Thanking you.
Sincerely,
Deepthi Kondapalli
Enclosure: Resume

2. DEEPTHI KONDAPALLI
Mobile: 09030275188, 08712352942~ E-Mail: kondapallideepthi@gmail.com
Snapshot
 A profession with experience in, Regulatory Affairs and Quality Assurance in the
pharma industry.
 Possess strong research, analytical, problem-solving and interpersonal
communication skills.
 Experienced audits: MHRA.
Areas of Expertise
 Communicating with various departments like R&D, Production and QC to facilitate
the development and implementation of registration strategies to expedite the
registration of products and life cycle optimization
 Coordination with internal customers ie plant QA, QC and CQA for submission
requirements and post approval regulatory commitments.
 Deft at submission guidelines of various procedures ie DCP/NP/MRP.
 Preparation of trend analysis charts and annual product quality reports.
Professional Experience
Nov’15-till date: Aurobindo Pharma Limited, Vizag as Executive-Quality Assurance
Key Deliverables:
 Review of product documents i.e. batch manufacturing records, batch packing
records, process validation protocols/reports, hold time protocols and reports against
applicable standard operations procedures/policies.
 Review of analytical data i.e. certification of analysis (RM/PM/IP/FP)
chromatograms of HPLC. DSC, IR, UV etc.
 Review of stability data against guideline requirement for submission.
 Preparation of online trends for process, analytical parameters and preparation of
Annual product quality review.
 Knowledge on various post approval changes for EU/US markets.

3. May’14 to Nov’15: Aurobindo Pharma Limited Research Centre-I, Hyderabad as
Research Associate-Regulatory Affairs
Key Deliverables:
 Interacting with cross functional department for submission requirements subsequent
compilation and registration of drug products in various countries. Coordinating with
customers for customer specific filings.
 Preparation and Compilation of the dossiers as per the current prescribed guidelines
of the respective regulatory authorities in eCTD format.
 Submission of the dossiers to the health authorities and accomplish the interactions
with them during the authorisation phase.
 Ensure documentation complies with regulations for international submissions.
 Tracking of MAs with ongoing Variations, Renewals, Withdrawals and MA transfers
on regular basis.
 Accomplishing the task of updating PSUR database for products on regular basis.
 Preparation of documentation for different types of Variation procedures and
Renewal Procedures to the Marketing Authorizations and responsible for timely
submission of variation & responses if any.
 Updating the knowledge on regulatory guidelines, legislations, requirements,
processes and procedures.
Academic Credentials
 M. Pharm in Pharmaceutics from Karnataka College of Pharmacy, Bangalore with
81 % in the year 2013.
 B. Pharm from K.M.C.H College of Pharmacy, Coimbatore with 79.1% in the year
2011.
 Professional Diploma In Clinical Research course from Catalyst clinical service Ltd,
Delhi in year 2009.
IT FORTE: Conversant with MS Office, ERP and Internet/Email Applications.

4. Project Work/Research Papers
 P.G Project Work: Design, Optimization and Evaluation of Montelukast Sodium
Oral-SITU GEL.
 U.G Project Work: U.V Spectrophotometric Estimation Of Voriconazole in Tablets
Dosage Form.
 UV Spectrophotometric Estimation of Voriconazole in Tablet Dosage Form.
Research Journal of Pharmacy and Technology November 2011.
 Determination of Independent Variables for the Losartan Mucoadhesive Buccal
Tablets using Central Composite Design. American Journal of Pharm Tech
Research 2013.
Personal Details
Date of Birth : 20th
Mar, 1990
Languages Known : English, Telugu and Tamil
Marital Status : Married
Strengths : Quick learner, Hardworking, Taking initiative, gel along with team
members.
I hereby declare that the above provided information is genuine and reliable as of my
professional knowledge.
Date: Deepthi Kondapalli