K. Sailaja has over 8 years of experience in regulatory affairs. She holds an M.Pharmacy degree and has worked for several pharmaceutical companies in regulatory roles, including Manager of Regulatory Affairs at Micro-Therapeutic Research Labs and Associate Manager of Regulatory Affairs at Novartis Animal Health. Her responsibilities have included filing applications, ensuring compliance, coordinating with other departments, and preparing and reviewing documents. She is proficient in MS Office, has attended training programs in communication and presentation skills, and aims to work in a challenging position that allows her to utilize her skills and experience.

1. K. SAILAJA
E mail: lakanam.sailaja@gmail.com Ph. No. : 9791280556
Career Objective
To workin a challenging position for an esteemed organization that provides the best opportunities to utilizemy talent
and skills for professional and personal development. Motivated achieverwho is recognized forcombining program,
excellence, integrity and innovation with best practices and disciplined attention to achieving immediate and long term
goals and Objectives.
Career Summary
 M.Pharmacywith more than 8 Yearsof Work Experience
 Worked with Micro-Therapeutic Research Labs Pvt. Ltd as
Manager-Regulatory Affairs.
 Worked with Novartis Animal Health as Regulatory Affairs
Associate Manager II - Regulatory Affairs
 Worked with Micro Labs Ltd, Bangalore, India as Executive -
Regulatory Affairs.
 Worked with Matrix Laboratories Ltd. Hyderabad, AP, India as
Officer- Regulatory Affairs
 Worked as Outsourced employee of HR Chambers outsourcing
Pvt Ltd in Dr. Reddy's Laboratories Limited, Generics division,
Bachupally as Documentation Officer-Regulatory Affairs.
 Worked with Teena Labs Pvt. Ltd as Analytical Chemist in
Quality Control department.
Work Experience
Tenure:May2015-Aug2015
Designation:Manager-RegulatoryAffairs
Employer:Micro-TherapeuticResearchLabsPvt. Ltd., Chennai.
JobResponsibilities:
 Support filing of BENOC applications.
 Involved in Sample segregation, Registration, Screening and CRF
review activities.
 Identification of trainers and provide training schedule for new
and existing staff as per the requirements.
 Ensuring periodic training for the existing staff
 Ensuring that the new and existing staff is adequately trained
before putting him/her in the assigned job.
New No: 6, Old No 18, Eswaran Colony, 2nd Street,
Sarvamangala Nagar, Chennai- 600061
Education
Year 2010
M. Pharmacy from JNTU,Hyderabad (67%)
Year 2003
B.Pharmacy from "Sultan-Ul-Uloom college
of Pharmacy" (Affiliated to JNTU,
Hyderabad) (73%)
Year 1995
SSC from Nalanda Vidyalaya High School
(79%)
Achievements
 Timely completion and responding to
the queries related to labeling.
 Handled a team of 4 members and
involved in resolving issues araising out
of sample analysis of certain typical
drug products thus enabling customer
satisfaction in giving COA reports
timely
Key assets
 Biotech basics in addition to Pharma
knowledge.
 Office Essentials: MS- Word, Power
Point, Excel,Adobe page maker

2.  Ensuring the training of personnel in compliance with GCP, GLP
and Quality system
 Provide training as per the recommendation of QC/assigned
person.
 Responsible for review to ensure the completeness of the
training files of the staffs
 Any other job assigned by the management, time to time.
Tenure:Sep2013 -Jan 2015
Designation:RegulatoryAffairsAssociateManagerII-
RegulatoryAffairs
Employer:NovartisAnimal Health,Hyderabad.
JobResponsibilities:
 Responsible for thorough understanding of local requirements
and has general understanding and knowledge of regulatory
requirements forall countries supported.
 To plan, co-ordinate and execute all regulatory activities of the
assigned products in collaboration with global business partners
ensuring successfuland timely completion of projects.
 To ensure regulatory compliance by timely preparation and
submission of Annual Reports, Post-approval Variations and
Renewal Applications.
 Responsible for ensuring professional planning, competent RA
input, efficient registration and maintenance of the registrations
of existing marketing authorizations in accordance with business
needs directions and strategies. Plan, direct and coordinate all
regulatory activities of the assigned products or areas of
responsibility (e.g., CMC) in collaboration with (according to
applicability): country regulatory professionals, local CBU,
project teams, and/or competence centre regulatory
professionals, ensuring successful implementation, follow
through and completion of tasks.
 Prepare, write and review Part 2/CMC documents (e.g., detailed
and critical summaries, tabulated summaries) for products in
development to be newly submitted globally and for any post-
approval submission, according to the latest regulatory
requirements of the focuscountries with minimal oversight.
 To perform gap analyses in preparation of new submissions of
established products to the different markets.
 Ensure regulatory compliance by creating awareness of
requirements and guidelines, facilitating timely submissions and
strict participation in the global/local change control operations.
Ensure regulatory- compliance by timely submission of
variations.
 Apply procedures and systems necessary to maintain proper
records and support adequate controls.
 Perform other related duties and assignments as required by the
business and directed by management.
Strengths
 Positiveattitude
 Consistency
 Coordination and interpersonal
relationships
 Creative extensions to the existing
operations and general management
allow me to add value to the operations
execute.
Trainings attended
 Undergone training “Communicating
with Impact” as set forth by Dale
Carnegie & Associates, Inc
 Undergone training “Presentation
Fundamentals” as set forth by Dale
Carnegie & Associates, Inc
Rewards & Recognition
Achieved “Appreciation Team Award” twice
Personal Dossier
Date ofBirth
30th October1979
Nationality
Indian
Marital status
Married
LanguagesKnown
English, Hindi and Telugu

3. Tenure:Feb2011 - Mar2013
Designation:Executive -RegulatoryAffairs
Employer:Micro LabsLtd., Bangalore
JobResponsibilities
 Interacting with the respective country managers to maintain up-
to-date status of the product for any change in the guidelines,
prioritization, and submission to MOH & market scope for quick
approvals/renewals.
 Registration of Pharmaceuticals in East African region (Kenya,
Uganda, Nigeria, Zambia, Ghana, Rwanda, Tanzania), French West
African region (Ivory coast, Cameroon, Benin, Mali, Congo, Togo,
Burkina Faso, Gabon, Senegal), Sudan, Srilanka, Iraq, Vietnam &
Myanmar
 Preparation and submission of dossiers as per regional format
and also in CTD/ACTD formatfor ROWmarket.
 Review of quality and analytical data as per the Pharmacopoeia,
Spec, STP, Batch records, Process validation protocol and reports,
Pharmaceutical development reports, Stability protocols and data,
Packaging material data for the purpose of compilation of the
dossier.
 Browsing particular sites for clinical study reports and to add up
in the dossier if required.
 Coordinate with Active Pharmaceutical Manufacturers (APM) for
the technical data required forregulatory submission.
 Liaison with various departments like R&D, Analytical
Development, QC, QA, Productionand SCM
 Monitor status and to apply forproduct licenses.
 Responsible for the timely submission of re-
registrations/Renewals to support changes to manage the
regulatory product life cycleas applicable.
 Review of art works with respect to regulatory requirements.
 Compilation and sharing of approval product details (product
approval notes) upon receipt of product approvals
 Preparation of tender dossiers, taking the production batch
repacking the samples in E/F foil if it is African market as per the
need of the customers.
Tenure:June2007 - July 2008
Designation:Officer-RegulatoryAffairs
Employer:MatrixLaboratories Ltd.,Hyderabad.
JobResponsibilities:
 Effectively executing for timely and error free submission of CTDs
for US market.
 Review of all documents submitted with US market, identifying
error & providing solution for those errors for submission of
flawless documents, thereby assuring the regulatory compliance
is met.

4.  Responsible for the timely submission of post approval
supplements/annual reports to support changes to manage the
regulatory product life cycleas applicable
 Coordinate with Active Pharmaceutical Manufacturers (APM) for
the technical data required forregulatory submission
 Review of documents like batch manufacturing records, stability
protocols and the data, Validation protocols and the data, raw
material, finished product and shelf life specifications for
regulatory compliance.
 Updating of regulatory information & guidance at different
stages of product development.
 Liaison with various departments like R&D, Analytical
Development, QC, QA, Productionand SCM
 Preparation and review of package Insert and side-by-side
comparison
 Review of art work.
Tenure:December2005 -March2007
Designation: DocumentationOfficer -RegulatoryAffairs
Employer: Outsourced employee of HR Chambers outsourcing
Pvt Ltd worked in Dr. Reddy's Laboratories Limited, Generics
division,Bachupally,Hyderabad.
JobResponsibilities
 Handled labeling section of ANDA and dealt with their deficiency
responses.
 Regular monitoring of nlm/fda/Innovator websites for initiating
and forconstant updation of PIL's.
 Incorporating practices of previous deficiencies while
documenting PILsto avoid repeated deficiencies.
 Review of art work.
 Review of documents and assisting team members in
compilation of ANDA and in other department activities.
 Handled annual reports of INDs, NDAs, and ANDAs.
 Having thorough knowledge of various sections in ANDA in
traditional format withcomplete idea in production of ANDA.
 Updation of databases for deficiencies, Amendments and
Supplements.
 Performadditional duties as assigned by RA project leader
Period:September2003 - November2005
Position:Analytical Chemist-QualityControl Dept.
Employer:TeenaLabsPvt. Ltd., Hyderabad.
JobResponsibilities:
 Handled Instruments like HPLC, GC, FTIR, UV-Visible
spectrophotometer, Dissolution Apparatus, Disintegration
Apparatus, Polarimeter, Karl Fischer Titrator as a part of routine
including finished product and wet analysis

5. Declaration
I declare that the information and facts provided above are true to the best my knowledge and belief.
analysis including finished product and wet analysis
 Preparation of COA's and corresponding documentation works.
 Effectively executedcustomer complaints and inspections.
 Conducted training classes in the organization to the various
aspirants regarding testing techniques and also handling
techniques of various laboratory equipments in association with
SISI, Balanagar, Hyderabad
