www.famycare.com Famy Care Ltd Mahape : Regulatory Affairs

[mskavi]

Famy Care Ltd.
http://www.famycare.com

Keywords: ANDA, CTD, eCTD, FDA
Designation: Manager Regulatory Affairs
Experience: 5 - 8 Years
Location: Mahape
Education: UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 05 Jan 2009

Job Description
Experience of ANDA for mixed dose combination in US, should able to compile dossiers for regulated market in CTD / eCTD format, should able to handle queries of FDA, review of data, experience of preparing module I, II, III, IV & V

Desired Candidate Profile
B.Pharm / M.Pharm with 5 to 8 years of experience. Computer savvy, able to compile dossiers in CTD / eCTD format, communication skills, etc.

Company Profile
Famy Care is one of the fastest growing companies with 68% of growth rate. Leaders in female health care products i.e. oral contraceptives & IUD’s etc. We have got tie-up with one of the third largest generic group i.e. Mylan.

Corporate Office:
3rd Floor, Brady House,
12/14, Veer Nariman Road,
Fort, Mumbai - 400 001.
India.
Tel: 91-22-3028 9655
Fax: 91-22-3028 9656
E-mail: ho@famycare.com

Manufacturing Unit:
Plot No. 1608 & 1609,
G.I.D.C. Sarigam - 396 155
Gujarat,. India.
Tel: 91-260-2780674, 2780502
Fax: 91-260-2780574


Manufacturing Unit:
Plot No. 688/10/11,
Siddhi Vinayak Industrial Estate,
Opp. Somnath Temple, Somnath,
Daman - 396 210. India.
Tel: 91-260- 224 2484, 224 3279
Fax: 91 -260-224 3279

Manufacturing Unit:
Famy Care Ltd.
Verna, Salcette,
Goa - 403722
India.

[Guest]

Is there any vacancy in Regulatory for M. Pharm fresher? I am M. Pharm (Pharmacognosy) fresher from Mumbai University.

[arunaballal]

Ballal Aruna Sudam-
Email : arunaballal AT gmail.com

Career objective :
Seeking a challenging position in a reputed pharmaceutical industry, where I can utilize my talent and skill to contribute in the success of industry.-

SUMMERY
Talented and highly motivated youngster with huge creativity and grasping ability. B.Pharm technically sounds with subject knowledge and willingness to learn new things. Ability to apply new concepts more efficiently and effectively. Leading a team work for best output with full dedication towards my goal. Possess a flexible & detail oriented attitude.

KEY SKILLS : Leadership, Creativity, Communication skills.--

EDUCATIONAL QUALIFICATION :

-INDUSTRIAL TRAINING :
Completed one month training in ‘Wokardt Pvt. Ltd.’ as per the university curricula.

PROJECT WORK :-
“Secondary Metabolites In Plant Tissue Culture” had been submitted in May 2009 to Shivaji University Kolhapur.

EXPERINCE-
Six months worked in “Mistair Health & Hygine Pvt Ltd Kolhapur” in QUALITY ASSURANCE department as Management Trainee.
“Maneesh Pharmaceuticals” Ltd. Mumbai. As Regulatory Officer From 20 May, 2010 to till-date.
-
ACHIEVEMENTS :-
Participation in the workshop on TECHNIQUES IN MOLECULAR BIOLOGY by Bioera Medical System in 2008.
Participation in National workshop on scientific foundation in pharmaceutical product development in2008-2009.
Appreciation in Special OLYMPICS – BHARAT in 2005.

Current Job Profile :
Input of dossiers in eCTD software (Infotehna) for Europe Submission
Preparation of dossiers for ROW Markets such as Nigeria, Namibia, Phillipines,
Myanmar, and Malawi, Mali, Senegal per the guidelines provided.
Responding to queries received from different Regulatory Agencies and ensuring that
registration approvals are granted without undue delay.
Co-ordinate and follow up with other departments such as Manufacturing, Product
Development, Quality Control and Quality Assurance for regulatory Requirements.
Review of documents for dossier preparation as per regulatory guidelines.
Preparing the Electronic CTD Dossiers (eCTD in XML format) in the new software.
Review and submission of Artwork / Final Packing Material of registration samples
as per the Regulatory Requirements.
Preparation of Applications for COPP, Product License & free sale certicficates.

WORK DONE :
Name of dossiers published in eCTD format :
1.Rifampicin 150mg/ Isoniazid 75mg/ Pyrazinamide 400mg/ Ethambutol HCL 275mg
Tablets
2 .Ethambutol Hydrochloride (400mg) Tablets
3. Streptomycin Sulphate Injection BP 1g
4. Febrinil 650mg Tablet
5.APAP 500mg USP Tablet
6.APAP 650mg Tablet USP.

Name of dossiers published in A CTD format :
-1. Co-amoxiclav Susp 156.25 mg/5ml, 60ml-
2. Co-amoxiclav Susp 228.50 mg/5ml, 70ml
3 .Co-amoxiclav Tablets USP 625mg
4. Co-amoxiclav Tablets USP 1000mg
-Declaration :
I hereby declare that the above information furnished by me is true to the best of my knowledge and belief


Thanking you-

Yours-faithfully

-Aruna S.Ballal.

[Unregistered]

Curriculum Vitae
Varsha Babanrao Divekar
Email : varshadivekar27 AT gmail.com , varshdivekar1 AT yahoo.com

OBJECTIVE :
To learn and function effectively in an organization and be able to deliver to the bottom-line. To constantly upgrade my knowledge and skills and make a difference in whatever I do.

CURRENT STATUS :
Currently working at Cian Health Care Pvt. Ltd, Pune. from Sept-13 to till date.
Position : Regulatory Affairs Executive
Job Profile :
** Preparation of registration and Re-registration dossiers as per Registration guidelines of the respective health authority in CTD, ACTD & Country specific formats for African, Latin American, South-east Asian and Middle-east Asian countries
** Tender documentation : Organization & provision of technical documentation & samples for various tenders within stipulated time frame.
** Knowledge and experience in handling regulatory requirements, functions with Solid oral dosage forms, liquid orals, injectables, Nutraceuticals.
** Preparation of technical queries responses raised by different regulatory health authorities.
** Maintenance of country related registration correspondence like emails, marketing authorization certificates, registration status, Export purchase orders etc
** Co-ordination with various departments in the company & different Mfg. sites (Loan Licn and P2P) for collection of various technical documents as required for registration & Tender purpose.
** Review of various technical documents used in pre-registration and post-registration activities.
** Checking of product artworks as per the registration packaging / labeling guidelines of the country for product registration & export consignment.
** Arrangement of registration samples for tender as well as registration purpose.

Additional Experience :
Company : Batavia Exports International, Pune. from Nov-12 to Sept 2013.
Position : Regulatory Affairs Executive
Job Profile :
** Handling Formulation Development & Regulatory affairs for Europe market(Generic Formulation).
** Handling projects of regulated & non regulated market(Tablets, capsules, Suspensions, Lozenges,Injectables)
** Documentation in all steps of formulation development including validation protocol, stability study protocol, proposal of product specification (In-process and release) and product development report (PDR). Prepare detailed technical reports of the studies completed and periodic reports of ongoing projects.
** Coordination with factory, R&D, QA, QC, Packing, Production departments for analytical data requirement, Registration samples & Technical documents.
** Checking and reviewing product artwork for country specific regulatory compliance etc.
** Reviewing documents (required for regulatory submission, manufacturing & technology transfer) Specification & STP of product & API, Validation protocols & reports, Process validation, Cleaning validation and Analytical method validation, Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR), Packaging Material Specification (PMS).
** Email communication and Acknowledgments.
** Literature Search.
** Sending samples to different countries and tracking of the same.
** Monitoring, control and Handling of technical queries from customer.

Lecturership : ST College of Pharmacy, Shirur(Pune) from Aug. 2009 to Jun. 2010
1 Year as a Lecturer in ST College of Pharmacy, Shirur(Pune).
Job Profile :
** Responsibility of taking lectures and practical’s of Pharmaceutics and HECP.
** Placement officer
** Work as a External for board examination at various Pharma colleges.

ACADEMIC SUMMERY :
Master of pharmacy (Q.A.) from Pune University with 72.64% (First class with Distinction).
Bachelor of pharmacy from Pune University in April 2009 with 73.91 %( First class with Distinction).
Higher secondary certificate examination from Maharashtra board in March 2005 with 72.67% (First class).
Senior secondary examination from Maharashtra board in March 2003 with 82.26% (First class with Distinction).

ACADEMIC ACHEIVEMENTS :
Qualified Graduate Pharmacy Aptitude Test (GPAT) 2010.
Qualified in “General Course on Intellectual Property” organized by WIPO (World Intellectual Property Organization).
I. Publications :
Solubility enhancement and formulation of rapid disintegrating tablet
of Febuxostat Cyclodextrin complex published in Journal of Pharmacy Research (JPR),Feb.2013,(168-175).
“Solubility enhancement and dissolution rate of Ziprasidone by melt granulation technique” Imperial Journal of pharmaceutics & cosmetology, online journal, 2(2) : June 2012 (001-007).
Solublity enhancement of poorly soluble drug Febuxostat by melt granulation technique published in International Journal of Pharma Research and Development, Vol 4(06) : August-2012 (318 – 323)
“Spectrophotometric simultaneous determination of candesartan cilexetil and amlodipine besilate in combined tablet dosage form by dual wavelength, absorption corrected and zero absorbance method published in IJPRD, IJPRD, Vol 4(06) : August-2012 (311 – 317)
“Formulation and evaluation of Xanthan gum based floating tablet of Tramadol Hydrochloride” accepted in International Journal of Current Research and Review, July 2012.
“Isolation and Characterization of mucilage from Lepidium sativum linn. seeds”. International Journal of Pharma Research and Development, Vol 2, Issue 1, March 2010.
“Studies on anti-diarrheal activity of dalberjia sissoo roxb. in experimental animals.” African Journal of Pharmacy and Pharmacology, Vol 1, 2010.
“Characterization and dissolution profile of inclusion complexes of hydrochlorthizide with hydroxylpropyl beta cyclodextrin and formulation of fast dissolving tablet” communicated to Pharma Scan journal, July 2012

II. Research / Scientific Paper or Poster Presentation :
Presented a poster entitled “Application of melt granulation technique for enhancement of solubility of ziprasidone” in National Level Conference sponsored by University of Pune at Maharashtra Institute of Pharmacy,Pune 2012
Participation and presented a paper in poster session in 63rd Indian Pharmaceutical congress held at Bengaluru 2011.
Participation and presented a paper in poster session in 59th Indian Pharmaceutical congress held at Varanasi 2007 on Pharmaceutical Technology.
Presented a poster in State Level Pharmacy Intercollegiate poster presentation competition held at RD College of Pharmacy Bhor.
Presented a paper in oral session in Inter-University Research Project Competition pharmacy category held at VPASC college Baramati, for Research festival Avishkar-2007.
Attending 3 days National Level Conference on “Novel Trends In NDDS” held at MIP, 2012
Attending 1 day State Level Seminar on “Standardization of Herbal Drugs : need & prospects” held at STCOP, Shirur.
Attending 3 day National Level Conference on “Advances & Trends in Drug Development Process” held at MIP, 2011

III. Extra-Curricular :
Work as Volunteer in “1st & 2nd Parliament of Indian Student Council Leaders” organized by MAEER’s MIT SOG, Pune, 2011, 2012.
Actively participated in inter college competition.
Computer Knowledge : Internet, Basic Computer knowledge (MSCIT course with 84%)

PROJECT WORK :
M.Pharm
Thesis Title : “Solubility enhancement and formulation of rapid disintegrating tablet of Febuxostat Cyclodextrin complex.
Thesis Guide : Dr. B. S. Kuchekar.
B.Pharm
1. In Pharmaceutics, on “Isolation, Characterization Of Mucilage From Lepidium sativum Linn. And It’s Evaluation As Suspending Agent”.
2. In Pharmacology, on “Evaluation Of Antidiarrhoeal Activity of Bark of Daibergia sisso roxb ”.

TECHNICAL PROFICIENCY :
1. UV spectrophotometer(Varian Cary 100, Perkin Elmer)
2. IR spectrometer (Varian 643)
3. HPLC (Waters PU-2080 Binary)
4. Dissolution apparatus (Electrolab)
5. Disintegration apparatus
6. Flame photometer
7. Water Shaker.

PERSONAL INFORMATION
Full name : Divekar Varsha Babanrao
Date of Birth : 24th November 1987
Mother tongue : Marathi
Religion : Hindu (Maratha)
Marital Status : Single
Languages known : English, Hindi, Marathi

DECLARATION :
I do hereby declare that the particulars of information and facts stated herein above are true, correct and complete to the best of my knowledge and belief.
PLACE :
DATE : Varsha B. Divekar