www.eurolife.co.in HEALTHCARE PVT LTD Mumbai : REGULATORY AFFAIR

[mskavi]

EUROLIFE HEALTHCARE PVT. LTD Mumbai, : REGULATORY AFFAIR EXECUTIVE
Website: http://www.eurolife.co.in
eurolife.co.in

Keywords: Regulatory affairs in parenterals,preparation of dossiers / obtaining licences. etc

Designation: REGULATORY AFFAIR EXECUTIVE
Experience: 1 - 2 Years
Location: Mumbai,

Job Description:
- PREPARATION OF DOSSIERS & SOLVING QUERIES
RELATED TO DOSSIERS.
- REGISTRATION OF PRODUCTS IN OVERSEAS MARKET

Desired Candidate Profile:
*SHOULD HAVE EXPERIENCE IN PHARMA INDUSTRY

Company Profile:
MUMBAI BASED WELL KNOWN FAST EXPANDING PHARMA CO. CURRENT TURNOVER RS. 75 CRORES

Address:
EUROLIFE HEALTHCARE PVT LTD
69A, MITTAL CHAMBERS
NARIMAN POINT
Mumbai,MAHARASHTRA,INDIA 400 021

To apply, send CV to Email Address: vacancy.eurolife@gmail.com

Keywords: Regulatory affairs in parenterals,preparation of dossiers / obtaining licences. etc

[Guest-IJT]

Name : amit kumar
Email : amitpharmacist AT gmail.com
Designation / Skillset : regulatory officer
resume for regulatory affairs

Resume :
CAREER OBJECTIVE
Seeking workplace where my skills and abilities could be best utilized up to full potential with an element of enhancement in knowledge.
ACADEMIC PROFILE
M. Pharm. From B.B.D.N.I.T.M.Lucknow in 2009 with 70.33%.
GATE Qualified with 99.12 percentile score in Pharmaceutical Sciences (GATE – 2007).
B. Pharm. From Dr. K.N.M.I.P.E.R.Modinagar, Ghaziabad in 2007 with 63.19 %.
D. Pharm. From S.B.D.I.P. Hanumantha nagar, Banglore in 2004 with 70.09%
B.Sc. From S.N.P.G.C. Azamgarh in 2001 with 51.05%.
Intermediate From S.N.I.C. Azamgarh in 1997 with 42.8%.
High school From S.N.I.C. Azamgarh in 1995 with 55.66%.
M. Pharm. PROJECT
Worked on ‘Formulation and evaluation of self emulsifying drug delivery system of nimodipine adsorbed on porous polystyrene beads’. This work is aimed at successful development and commercialization of new drugs in the pharmaceutical industry. The formulation strategies have been investigated to improve the solubility and the rate of dissolution to enhance the oral bioavailability of lipophilic drugs.
TECHNICAL SKILLS
Computer knowledge : Well trained in using various computer software such as Windows, MS office, Chemistry Software such as chemix, Data retrieval from various databases such as Pubmed, , Google scholar, Science direct, Scifinder etc.
TRAINING EXPERIENCE
Successfully completed 4 weeks training in Oral Liquids, Tablet and Capsule Sections at Anant Pharmaceuticals, Karnal
PROFESSIONAL ACTIVITIES
- Seminars presented in M. Pharm. Course on various topics.
- Attended 3days symposium organized by C.D.R.I. Lucknow & N.I.P.E.R. Raebareli. (March 24-26,2009)
- Attended 46th IHPA NATIONAL CONVENTION, 2009 & Sliver Jubilee Celebration of IHPA U. P. state branch. (Oct. 24-25,2009)
PROFESSIONAL EXPERIENCE
Working in IND-SWIFT LTD R&D, PANCHKULA , HARYANA as a Regulatory Affairs Officer from DEC 2010 till this date.
Worked in ACME Formulation Pvt Ltd, Nalagarh, HIMANCHAL PRADESH as Trainee Regulatory Affairs Officer from Jan 2010 till Nov 2010.
JOB PROFILE
- To strategize, review and compile registration dossiers for ASEAN and ROW countries.
- Compilation of Dossiers in CTD format (ACTD), handling all the queries related to filing registration of same.
- To respond, in a timely manner in consultation with responsible personnel of manufacturing, R & D, QC & QA, and to compile response documents and submit them.
- As required and directed, to formally assess Drug Master File (DMF) documentation supplied by manufacturer’s of Active Pharmaceutical Ingredients (API) against the current regulatory and internal requirements.
- To liaise with all appropriate Quality Assurance (QA) personnel, internal or external to company and related companies, in order to facilitate and to maintain a state of full regulatory compliance in respect of all company's marketing authorizations.
- Also to co-ordinate with Marketing department (respective country managers) and monitor Regulatory Affairs team and its activities
- To perform such other duties at a comparable level of responsibility, as may be required from time to time, in the interests of the company.
- To provide frontline support in the execution of regulatory strategies by collating data and compiling the basic information towards the preparation of regulatory dossier as well as the maintenance and updation of regulatory databases towards providing real time regulatory information on need, under the guidance and instruction of the supervisor.
- Preparation of insert for pharmaceutical products.
- Review and compilation of DCGI dossier.
- Preparation of specification and standard testing procedure for API, Excipients and finished product
- Handling of activities related with local FDA like COPP, product permission etc.
REFERENCE
Prof. Dr. Hardeep Wadhwa Mrs Suman Batra
President F&D and RA Manager R. A.
IND-SWIFT LTD R&D, PANCHKULA Nector Life Sciences Pvt. Ltd
E contact : hardeepwadhwa AT sify.com E contact: suman.batra24 AT gmail.com
Mr Jagmohan Kr Sharma
AGM F&D
Claris Life Sciences Pvt. Ltd.
E contact : sharma_jagmohan71 AT yahoo.com
I hereby solemnly declare that all the information provided here is as per the best of my knowledge.
Date :
Place : Amit Kumar
-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4181404
Date & Time : 27th May 2011 2:50 PM (UTC)
IP Address : 117.224.176.131
Browser Info : Mozilla/4.0 (compatible; MSIE 8.0; Windows NT 6.1; WOW64; Trident/4.0; GTB6.6; SLCC2; .NET CLR 2.0.50727; .NET CLR 3.5.30729; .NET CLR 3.0.30729; Media Center PC 6.0; InfoPath.2; .NET4.0C; BRI/2; MASN)
Predicted Country ;: India

[Guest]

Date : 03/01/2011
To,
Dear Madam,
Subject : Application for a post of Regulatory Affairs Executive in your esteemed organization
I, Mr. Prashant P. Shetty, have done B.Pharm from Konkan Gyanpeeth Rahul Dharkar College of Pharmacy, Karjat & am currently employed at Wockhardt limited for last 1 year. I would appreciate the opportunity to apply my skills on behalf of your company. For your examination, I have enclosed a resume indicating my education and work experience. I would be pleased if you consider me for department of Drug Regulatory affairs in your organization. I can be reached at the address and phone number below.
Thank you for your consideration and I look forward to hearing from you.
Sincerely,
Mr. Prashant P. Shetty
E-Mail :
Pras.1789 AT gmail.com
Pras.1789 AT hotmail.com
Pras_shetty AT yahoo.com

Interests and Hobbies :
Travelling, Reading, Listening Music & Singing.

Preferences
Location : Anywhere in India
Objective
Aspiring to work with professional organization, in Pharmaceutical arena using my
own domain knowledge and work experience and would strive my best through
sincere, hard, and aimed effort, thus helping in growth of organization.
Professional Qualification
Bachelor of Pharmacy (FIRST CLASS) from MUMBAI UNIVERSITY
Academic Qualification
2006 – 2010 Bachelor of Pharmacy
University of Mumbai,
Mumbai, India.

Computer Literacy
- Proficient in use of MS OFFICE applications like Word, Excel & Power point.
- Comfortable in working in Windows 98, Windows XP Operating Systems.
- Proficient in use of Internet Application in extracting information as well
as communication purposes.
Training acquired during Academic Years :
- One month Industrial training at Nulife Pharmaceuticals.
Work experience :
- Currently working as validation documentation specialist at Wockhardt Ltd.
Work Areas :
- Preparation and Distribution of SOPs to the Plant.
- Reviewing and Updating the SOPs after consulting with the concerned authorities.
- Co-ordinating with the various departments for compilation of information and drafting documents from the information gathered.
- Preparation of validation documents such as VMP, IQ, OQ, PQ, and supplementary documents and reviewing them to ensure completeness and free of deficiencies.
POSITIONS :
1) WOCKHARDT LIMITED
Executive-Trainee IT (from July 2010 till date)
Capabilities
- Knowledge of GAMP Guidelines.
Competencies
- Good Analytical skill,
- Organized and well structured at work,
- Committed to deadlines and schedules,
- Honest, Sincere and a Hard Worker with a high level of Integrity.
Notice Period : 1 Month

[yogesh.shani30]

anil1209@rediffmail.com
E-mail: office.cops@manipal.edu
To,
HR Manager,
Sub. : Application for job in Pharmaceutical Regulatory Affairs.
Dear Sir/Madam,

With due regards, I undersign, Yogesh C. Gujar , going to complete M. Sc.-II (Pharmaceutical regulatory affairs) of Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka-576 104 .
I will be fortunate enough if I could get this opportunity for job in your esteem industry in Regulatory Affair. I am interested in area of ANDA Filing, e-CTD submission, dossier preparation in ROW market ,DMF Filing, Registration of products, Follow up on submission, Evaluation of current regulations and maintaining proactive status of awareness of regulations and guidelines and their implications to the company’s, products and programs, , Pharmacovigilance.

I have enclosed my resume.
Thank You.
Yours Sincerely,
Yogesh C. Gujar
Yogesh C. Gujar
Email : yogesh.shani30 AT gmail.com
Professional Profile
I am competent, enthusiastic professional, who strives to develop and successfully implement progressive strategies with regulatory awareness for effectively meeting the challenges of global regulatory environments. I find my growth in the growth of the organization.
Objective
Work in a positive learning environment and delivering to my maximum potential.
Professional Qualification
Qualification Institution University / Board Year %
M.Sc. Regulatory Affairs Part II Manipal Advance Pharmaceutical Sciences Centre, Manipal, Karnataka. Manipal University pursuing
M.Sc. Regulatory Affairs Part I Manipal Advance Pharmaceutical Sciences Centre, Manipal, Karnataka. Manipal University June-
2010 67.70
B.Pharm Sharadchandra Pawar College Of Pharmacy,Otur, Pune Pune
University April-2008 58.30
D.Pharm
Sanjivani College Of Pharmacy, Kopargaon, A.Nager Mumbai
Board 2005 66.40
10+2 S.S.G.M College, Kopargaon, A.Nager H.S.C Board May-2003 57.50
10th New English School,kopargaon, A.Nager SSC Board May-2001 66.40
Areas of Interest
- ANDA Filing
- e-CTD submission.
- ACTD filing.
- Dossier filing ROW Market.
- Follow up on submission.
- Evaluation of current regulations and maintaining proactive status of awareness of regulations and guidelines and their implications to the company’s products and programs.
- Dossier preparation.
- Pharmacovigilance.
- DMF Filing
Knowledge Areas
- Familiar with various Regulatory Guidelines (ICH, FDA, EMEA, TGA, CDSCO, etc.).
- ACTD filing.
- Familiar with ROW countries guidelines.
- Knowledge of Code of Federal Regulations.
- Registration of New Drugs in India & US.
- Common technical Documents (CTD)-filing.
- Dossier preparation for various Dosage Forms.
- Electronic submissions in EU.
- GMP regulations-India, WHO, US, Europe.
- Pre & Post Marketing Regulatory Requirements.
- Response to Warning Letters.
- Intellectual Property Rights.
- Pharmaceutical process validation.
- Interfacing & strategic planning.
- Clinical Trials & Regulations.
Industrial Experience
- I worked as a trainee supervisor in parentral department for 5 month in CIPLA Pvt.Ltd, VERNA ,GOA
- I have accomplished an Industrial training programmed of 1 month at LEVA Pharmaceuticals Ltd, SINNAR, NASHIK
- I have completed 6 months academic project in BIOPLUS Pvt Ltd, Bangalore as a “Project Trainee in Regulatory Affairs”
Project on________________________________________1) Biosimilar/Biogenerics regulation for USA, Europe and India
2) Drug registration requirement in Latin American countries.
Seminars delivered
- Patent Infringement Issues In Indian Pharmaceutical Industries.
- Current regulation and trends in field of herbal dietary supplement and natural herbal product with special to U.S, India, Canada, Europe Countries.
- New drug application
- Coordination of Regulatory Affairs department to various departments.
Computer knowledge
Diploma in Office Automation.
Microsoft Word, Microsoft Excel, Microsoft Power Point, Internet applications.
Achievement :
1. winner in pharma wolly ball otur, pune
2. IPC 2010 presentation on dossier submission of biosimilar product in Europe
3. IPC 2010 presentation on regulations on dietary supplement and natural herbal product in Canada, India, USA
4. IPC 2010 presentation on status of adverse drug reaction monitoring

[Guest]

DHANJI LIMBASIYA
dhanjilimbasiya AT yahoo.com
OBJECTIVE
To work for a company that harnesses my potential to the fullest so as to help in its overall development and to aspire to excel in the field of Research and Development and widen the horizons with respect to the applicability of my role in variety of challenging business situation particularly in a global scenario.
Job Profile
At Astra Lifecare (India) Pvt. Ltd, 100% EOU
- Preparation of registration dossier as per various countries’ i.e. Kenya (CTD Format) Srilanka, Uganda, Tanzania, Venezuela, Ethiopia and Congo regulatory requirements for registration of product.
- Preparation of Master format as per country’s regulatory requirement guideline.
- Requisition to various department for required documents and follow up for the same.
- Review of documents, compilation of dossier documents.
- Handling of queries i.e. any additional requirement from various countries.
- Legal work i.e. Application for the product permission, Free Sale certificate and Certificate of Pharmaceutical Product to FDA and/or DCG (I).
- Communication for Bioequivalence data.
- Trademark Application and follow up of same.
At Amneal Pharmaceuticals (India) Pvt. Ltd
- Regulatory compliance related work wiz. Preparation and review of regulatory related documents for ANDA filing in accordance with eCTD format.
- GLP compliance in accordance with USFDA guideline
At Troikaa Pharmaceuticals Ltd.
- Preparation of registration dossier as per various countries’ regulatory requirements for registration of product.
- Review of documents like MFC, BMR, BPR, MPD, Specifications, Analytical Method Validation Protocol and Report, Process Validation Protocol and Report, Stability Protocol and Report, Product Development Report with respect to requirements of various regulatory agencies i.e. Europe as well as other agencies like Malaysia, Thailand- Asian Countries, African countries, Central America, Colombia, Azerbaijan, Belarus, Bolivia, Chile, Cambodia, Domician Republic, DR Congo, Franchophone, Sudan, Kenya, Philippines, Indonesia, etc.
- Communication with various departments regarding availability of documents required for registration within defined timeline.
- Justification of various deficiencies raised by regulatory agencies of aforementioned countries.
- To maintain registration amendment status and implementation of those changes in related documents.
- To maintain product registration status for various countries.
- To check feasibility of documents for dossier submission.
Professional Experience
Present Organization
Astra Lifecare (India) Pvt. Ltd, 100% EOU March-2011 to till date
Designation : Executive-IRA
- Preparation of registration dossier as per various countries’ i.e. Kenya (CTD Format) Srilanka, Uganda, Tanzania, Venezuela, Ethiopia and Congo regulatory requirements for registration of product.
- Preparation of Master format as per country’s regulatory requirement guideline.
- Requisition to various department for required documents and follow up for the same.
- Review of documents, compilation of dossier documents.
- Handling of queries i.e. any additional requirement from various countries.
- Legal work i.e. Application for the product permission, Free Sale certificate and Certificate of Pharmaceutical Product to FDA and/or DCG(I).
- Communication for Bioequivalence data.
- Trademark Application and follow up of same.
- To maintain registration amendment status and implementation of those changes in related documents.
- To maintain product registration status for various countries.
- To check feasibility of documents for dossier submission.
Amneal Pharmaceuticals (India) Pvt. Ltd July 2010 March 2011
Designation : Executive (Reviewer)-ARD
- Preparation and Review of Regulatory documents. Viz. Specifications API, Finished product as well as excipients, Analytical Procedures, Analytical Method Validation protocol and report, justification of specification, Reference standard and Material, Stability summary and conclusion, stability data, Post approval stability protocol and commitment
- GLP compliance related work in accordance with USFDA.
Troikaa Pharmaceuticals Ltd., Thol, Mehsana, Gujarat. May 2008 to July 2010 Designation : Sr. Officer (QA/RA)
- Preparation of registration dossier as per various countries’ regulatory requirements for registration of product.
- Review of various documents for product registration in Europe as well as Malaysia, Thailand- Asian Countries, African countries, Central America, Colombia, Azerbaijan, Belarus, Bolivia, Chile, Cambodia, Domician Republic, DR Congo, Franchophone, Sudan, Kenya, Philippines, Indonesia, etc.
- Preparation of validation and qualification protocol and execution of various validation and qualification activity viz, HVAC System, Autoclave, Dry Heat Sterilizer, Process validation of Parenteral and Tablets Manufacturing process, Purified water and Water for Injection generation and distribution system, Compressed Air and Nitrogen generation and distribution system, Visual Inspector for Parenteral as well Tablet & Capsules.
- Independently executed all qualification and validation activity for newly established plant of Troikaa Pharmaceuticals at Dehradun.
- Worked in In Process Quality Assurance in Sterile Manufacturing as well as oral dosages manufacturing i.e. Tablet as well Capsule.
Educational Qualifications
- Completed M. Pharm with specialization in Pharmaceutical Chemistry in March 2008 from Lachoo Memorial College of Science and Technology, Jodhpur, Rajasthan.
- Completed B. Pharm in June 2004 from L. M. College of Pharmacy, Ahmedabad, Gujarat.
Computer Proficiency
- Oprating Systems- Windows Vista, Windows XP
- Software- ISI Writer, MS Office 2007 and 2003 (MS word, Excel, PowerPoint and MS-Access), Adobe Acrobate Professional 6.0 and 9.0
Skills
- Experience of preparing documents in eCTD format.
- Good knowledge of eCTD and ACTD.
- Good knowledge of GMP, GLP, EU and USFDA guideline.
- Good communication skill with a penchant for hard work coupled with a positive attitude
- Effective Team Worker and punctual

INTERESTS\ HOBBIES
- Listening to music, dancing and travelling.
- Playing cricket, volley ball and playing all outdoor games.
- Reading Novels and Brain Teasing Puzzles.