www.neongroup.com Neon Laboratories Ltd Mumbai : Regulatory Affairs Manager

[mskavi]

Neon Laboratories Ltd. Mumbai : Regulatory Affairs Manager

Designation: Regulatory Affairs Manager
Experience: 5 - 8 Years
Location: Mumbai

Job Description:
*Head & Lead regulatory department. Trouble shoot issues pertaining to registration authorities.
*Handle queries received from various countries for product registration.
*Preparation of registration status.
*Handle change control & artwork approval for various countries as per requirement.
*Updating of specification as per latest edition of BP,USP,IP.

Desired Candidate Profile:
*Knowledge of IPR issues and that of various countries registration guidelines for registration with special focus on CTD format.
*Familiarity with registration requirements & hands-on experience in preparation of registration dossier of all markets.
*Strong understanding of Lab GMPs/SOP/FDA trends/ instrumentation & maintenance program.

Company Profile:
Manufacturer of Pharmaceutical Formulations backed by latest technology and creative marketing practices, enjoying commanding position in the Pharma Industry specifically in ANAESTHETIC / ONCOLOGY segment.

Address:
Neon Laboratories Ltd
140, Damji Shamji Industrial Complex,
Mahakali Caves Road,
Andheri - (East).
Mumbai,Maharashtra,INDIA 400093

Email Address: hr@neongroup.com
Website: http://www.neongroup.com

Keywords: Regulatory Affairs, Dossiers, DMF, API, Liasoning, Formulations, Regulatory , CTD , USP , IP , BP , Registration

[Guest]

To,

Sub: - Application for the suitable post in Formulation & Development, Technical Transfer & Process Development, Quality Assurance, Regulatory Affair.

Respected Sir,
I introduce myself as SANTOSH L. SHID M. Pharm. (Pharmaceutics). I have completed M. Pharma from K.L.E.S’ College of Pharmacy Hubli, Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka.

I would like to submit my application for the same along with my enclosed curriculum vitae for your kind perusal

Please send feedback message if considered suitable for the post. Thanking you for this initial consideration.

Yours Sincerely,


Mr. Shid Santosh Laxman

Shid Santosh Laxman
M. Pharm. (Pharmaceutics)
D. K. Tower Flat No- 103 D,
Plot NO- 18 B, Sector- 20 D,
Airoli, Navi Mumbai, (400708)
Maharashtra, India.
Ph. No: 0 - (22) - 27607220
Mo. No: (09702209075), (09324085893)
Email: santosh_shid@rediffmail.com

[muralikamarthi]

Hi am Murali Kamarthi working as executive in RA at NATCO Pharma Ltd. from one and half year. I am interested to work in your organization, please show me any opportunity in RA your company.

[Guest]

CURRICULUM VITTAE
Mr : BHUSHAN SHEWALE

E - Mail : bs15july AT gmail.com


OBJECT IVE :
To seek a challenging position in an organization that offers opportunity to explore my Qualification, Experience and Skills in the institute that provides a work environment that foster teamwork and allows independent responsibilities.
QUALIFICATION :
Course University/Board School/College Year of Passing Academic Grade
M.Pharm IInd Year Vinayaka Missions University, Salem Vinayaka Missions College Of Pharmacy , Salem
2011 First Class with Distinction
M.Pharm
Ist Year Vinayaka Missions University, Salem Vinayaka Missions College Of Pharmacy , Salem
2010 First Class with Distinction
B.Pharm North Maharashtra university, Jalgaon R.C. Patel College Of Pharmacy Shirpur
2008
First class
H.S.C.
Nashik K.B.H.Jr. College, Malegaon Camp, Tal : Malegaon,
Dist. : Nashik 2004 First class
S.S.C Nashik Samta Vidyalaya Tehere,
Tal : Malegaon, Dist.: Nashik 2002 First class
COMPUTER SKILLS :
- Ability to work on MS windows 98,2000,xp and window 7
- Ability to work on MS-Office
- Internet surfing
STRENGTH :
- Self Starter with Good Interpersonal Relationship Skills.
- Persistent and Thoughtful in undertaking Tasks with structured Work Habit.
- A good Team Worker as well as Target oriented Leader.
- Self-Confident, Flexible, and Adaptable to a changing Environment Focused.
AREA OF INTEREST
- Health Insurance
- Research & Development
INSTRUMENT HANDLING
- UV Spectrophotometer (Shimadzu 1700)
- Colorimeter
- Disintegration Apparatus
- Dissolution Apparatus (8 Station)
- HPLC WATER ( Data Ace software)
- PH Meter
- Melting Point Apparatus
INDUSTRIAL VISIT :
- Glenmark Pharmaceutical, Nashik.
TRAINING & EXPERIENCE :
- One month training in 2007 in NIRAMAY PHARMA,Nashik
- Six month training in 2010-11 Kshipra DRUG PVT. LTD, Dewas
- One month training in 2011 in Analog Lab., Hyderabad.
- One year Experience Of Marketing at 2008-2009 in CIPLA Ltd.
PROJECT :
- “Method Development and Validation on Balsalazide Disodium Dihydrate by RP-HPLC
OTHER PERSUITES :
- Attended One Day National Conference on “Recent Trend in pharmacology’’ at Salem, Tamilnadu.
- Attended Five Days Program on Leadership and Human Resource Development by CLHRD, Mangalore held at Shirpur.
- Attended two days workshop on “Biomedical statistics and Research methodology” at Shirpur.

[Guest]

MS. RENU A. PANDEY

Email :pandey.renu28 AT yahoo.com
CAREER OBJECTIVE
To enhance and develop my personal & professional skills by working in your esteem organization and give my best at the optimum level.
EDUCATION
- T.Y.B.sc. (Microbiology) with first class from Patkar College, Mumbai in April-2010.
- H.S.C. with First class from Thakur . College, Mumbai in Feb-2007.
- S.S.C. with First class from sjabv School, Mumbai in March-2005.
ADDITIONAL QUALIFICATION
.
- Working knowledge of Ms Office (Office Automation), FoxPro and other routine Internet & Computer Operations.
EXPERIENCE[]: FRESHER