Quality Assurance Management
Resume:
CURRICULUM VITAE
ANKUR SHARMA
S/o Shri S.K.Sharma
Distt: Haridwar
(Uttarakhand) 249404
***************@*****.***
Career of Interest: Drug Regulatory Affairs
Objective: To achieve responsible and challenging position that will allow
me to explore my capabilities, skills and sense of dedication towards my
duties with the sole aim of watching the progress of the organization.
To plan & execute all activities necessary for the registration of new
products & line extension indications.
Totally 2+ years experience in International regulatory affair - in
formulation companies as follows:
Present scenario: Currently Working at WHO GMP certified company Syncom
Healthcare Ltd., Dehradun, (UK) as Executive Drug Regulatory Affairs from
August 2011 to till date.
Job Responsibilities:
> Preparation, Review and submission of Technical documents/Dossiers
(CTD & ACTD format) related to Regulatory affairs for export of
Pharmaceutical Formulations.
> Checking and reviewing product artwork for country specific Regulatory
compliance.
> Checking of Master Formula Record, Site Master File, COPP, FSC etc.
> Participate in the regulatory activities of full spectrum of
formulation development.
> Review the documents at each stage of formulations development.
> Highlight the regulatory issues that can be there and try to resolve
them.
> Coordinate with F&D, AR&D, QA, etc. to collect the complete set of
documents.
> Coordinate with PPIC for packing material artwork and colour shade.
> Ensure the documents are error free and have minimum/no deficiencies.
> Respond to the queries of Regulatory authorities and customers on
time.
> Review the process change proposals and provide guidance on change
proposals.
> Develop the Global Regulatory strategies.
> Monitoring and Checking Of Registration And Re-Registration Dossiers
Of Formulations Including Prescription Products, OTC Products, Semi-
Regulated Countries And Non-Regulated Countries.
> Comply with internal operating procedures and global regulatory
requirements
> Develop, implement, maintain and review procedures and processes to
ensure regulatory compliance of packaging, labelling and promotional
materials
> Generation and approval of labelling and Instructions for Use
> Prepare documentation and provide support for the filing of regulatory
submissions for International Authorities within required timelines
> Write, review and maintain regulatory files such as technical
documentation, quality records, routine reports and regulatory agency
communications
> Respond to requests for regulatory affairs information
> Provide input to Company activities including the risk management
process, process and procedure improvements, management review and
support new product development activities
> Participate in internal meetings such as CAPA, complaints, material
review board and change control board
> Review document and product changes for regulatory submission impact
> Support equipment, system and process validation in-house and with
suppliers
> Provide regulatory input and appropriate follow-up support to
inspections and audits (Notified Bodies, etc)
> Make Company management aware of changes and trends in the regulatory
environment.
> Interacting with the appropriate regulatory bodies on specific project
/ product issues as required
> Interface with regulatory authorities on strategic regulatory and
technical matters, as appropriate
> Review regulatory documents for consistency and quality
> Secure import/export license for study medication and management of
the import/export process
> Acquire and maintain current knowledge of applicable regulatory
requirements and scientific/technical issues in the region and
discipline areas relevant to assigned projects
> Participate in regulatory affairs meetings and training initiatives,
project team meetings, and maintain relationships with other
departments, and sponsors
> Assist in the development and revision of local regulatory processes
and SOPs
> Literature survey.
Previous Company: WHO GMP certified company Akums Drugs & Pharmaceutical
Ltd. Haridwar (U.K.) as Officer Drug Regulatory Affairs from August 2010 to
July 2011.
Job Responsibilities:
> Preparation, Review and submission of Technical documents/Dossiers
(CTD & ACTD format) related to Regulatory affairs for third country
export of Pharmaceutical Formulations.
> Extensive practical experience of the authoring and compilation of
Module 3 (Quality Part) documents.
> Compilation Stability Report for Semi-regulated & Regulated Markets.
> Good hand in preparing Documents for quality part.
> Checking of artwork & various other related technical documents.
> Ensuring the compliance of proper documentation, registration samples
and pharmacopoeia standards to MOH authorities of Thailand, Ukraine,
Russia, Philippines, and Vietnam as per ICH guidelines in ACTD/CTD
format.
> Create a check list for all documents available and maintaining list,
documents and records.
> Sorting out Technical Queries Received from Agents and Health
Authorities of Respective Countries for Registration of Products.
> Co-Ordination with F&D, AR&D, Production, Quality Assurance, Quality
Control & Packing, for Technical Data.
Professional Qualifications:
|Session |Course |University |College |Result |
|2012 |PhD |S.V.U. |Sri Venkateshvara University |Pursuing |
|2011- Yet|PGDPRA |Jamia Hamdard, |Distance learning program |69.12 % |
| | |New Delhi | | |
|2008-2010|M.Pharma (Pharm.|RGUHS Karnataka,|Bharthi College of Pharmacy, |82.19 % |
| |Biotechnology) |Bangalore |Mandya (Karnataka) | |
|2003-2007|B.Pharma |RGUHS Karnataka,|Bharthi College of Pharmacy, |64.80 % |
| | |Bangalore |Mandya (Karnataka) | |
Summer Training & experience:
> Completed a one year of project & internship on thesis topic "Anti-
Bacterial Effects of Metabolites Produced by Actinomycetes Collected
from Soil Samples from Bank of Indian Rivers" from Bharthi College of
Pharmacy, Mandya (Karnataka).
> 45 Days industrial training in Pacific Pharmaceuticals Pvt. Ltd.
Bangalore, Karnataka.
Knowledge, Skills & Competencies:
> Ability to check and analyze scientific data and information provided
knowledge for the purpose of regulatory activities such as various
analytical techniques, analytical validation Protocols/Reports.
> Knowledge of regulations and guidelines for pharmaceutical products.
> Knowledge of technical aspects of product manufacture including
quality control and compliance.
> Work precisely as per procedures, rules & regulations.
> Recognize recurring issues and analysis of their cause in order to
reach a solution.
> Excellent verbal and written communication skills
> Appropriate English language skills
> Strong computer literacy e.g. MS Word, Excel and PowerPoint
> Good organizational, record retention and time management skills
> Knowledge of the various types of regulatory documents required and
required content
> Knowledge of regulatory procedures for US FDA, EMEA, MEDSAFE, TGA,
TTMRA, NAFDAC, BFAD, MCC, DDA, MHL&W, KFDA, CDDA.
> Knowledge of regulatory procedures for ICH, cGMP, GCP, GLP &
Biopharmaceuticals.
> Knowledge of regulatory procedures for IND submission, NDA submission,
ANDA submission, Pre clinical Trials & Clinical trials in association
with Good Pharmacovigillance Practices & PSUR.
> Knowledge on complete electronic online submission (e-CTD).
> Knowledge of ISO 13485 & ISO 14971.
> Knowledge to manage the translation process for labelling technical
and regulatory documents
Dossiers for different dosage forms:
> Oral Solid Dosage form: Tablet, Capsule: Hard Gelatin & Soft Gelatin,
Dry Syrups.
> Oral-Liquid form: Syrups, Suspension & Jelly formulations.
Desired countries for which Dossiers prepared:
Asia: Philippines, Sri lanka, Vietnam, China, Nepal, Thailand, Malaysia,
Cambodia, Malaysia,
Europe: Belarus, Georgia & Ukraine.
Latin America: Cameroon, Costa Rica, Chile, Guateamala & Cuba.
Africa: Nigeria, Francophone, Ghana, Malawi, Kenya & Libiya.
Gulf: Kuwait & Yemen.
C.I.S. Countries: Tajikistan & Ukraine.
South America: Venezuela.
Russia & Canada.
Strengths:
Smart working, Self-confidence, Positive thinking, Co-operative
[pic]
Personal Details:
Sex : Male
Marital Status : Unmarried
Registration Number : 4220 (Uttarakhand Pharmacy Council)
I solemnly declare that the above information are true and correct to the
best of my knowledge.
Date:
Place: Dehradun
ANKUR SHARMA
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