www.biocon.com Bangalore : Regulatory Affairs, Clinical Development Manager

[muthukalee]

Manager - Regulatory Affairs - Mabs
Requirement : Manager - Regulatory Affairs - Mabs - HC/JC/138/2011
Job Category : Medical/Healthcare/Bio-Tech
Location : Bangalore
Experience : 9.00 to 12.00 years
Education : MPHARM, MS II

Skills : Strong knowledge and experience in handling regulatory requirements, functions with Biologicals/API/Sold Dosage particularly with filing with USFDA and EU for the final marketing approval (NDA, ANDA)
** Handling of Regulated /ROW markets and with knowledge on non-clinical, clinical and BA/BE studies with Labeling requirements, electronic submission would be an added value.
** Ability to evaluate weakness and provide training and develop strategies to strengthen the weaker skills in the team.

Job Description :
** To ensure the filing of required regulatory documents on time as per regulatory norms, take active participation from start of the project and give Regulatory strategy inputs to the team.
** Liaise with Regulatory agencies, partners, customers, agents.
** Lead a team dedicated for a project and be a part of any Regulatory inspection.
** Play an important role in any decision making.
** Review of Dossiers, regulatory documents, response to deficiencies and guide team members.
** Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
** Perform Gap analysis

Associate Scientific Manager - Clinical Development
Requirement : Associate Scientific Manager - Clinical Development - HC/JC/835/2011
Job Category : Medical/Healthcare/Bio-Tech
Location : Bangalore
Experience : 2.00 to 4.00 years
Education : MBBS, MD/MS

Job Description :
Define TPP and draft CDP for the assigned projects, update the same and keep updated based on inputs from various line functions
Medical monitoring of the trials, point contact for all safety and medical questions for assigned trial
Will author and sign off on : Protocols, IB, IND/CTA clinical sections, briefing books, CSR, clinical dossier and publications
Maintain effective relationships with key investigators to ensure high scientific quality and relevance of trial design and endpoints.
Will have direct oversight on operations team. Accountable for the trial metrics- FPFV, LPLV, DBL and CSR timelines, the medical expert will be the driver of the team performance to achieve milestones for the project.
Lead investigator meetings and advisory boards

http://www.biocon.com/biocon_careers_job.asp
http://111.93.133.153/Candidate%20Po...p/Default.aspx

Contact Us :
Biocon Foundation
20th KM Hosur Road,
Electronic City,
Bangalore – 560 100
India

[Guest]

From,
SHAH CHAINESH NARENDRABHAI
DIST-VADODARA(GUJARAT).
E-mail : chainesh_26 AT yahoo.com

To,
The Head of Department

SUB. : - An Application for the suitable post (R & D/QA/RA).

Respected Sir,
I came to know about the vacancy in your organization through some reliable sources for which I offer my application for the above mentioned post.

I hereby attach my complete bio-data for your kind consideration & I will produce all my original testimonials at the time of my personnel interview.
I request you to accept this application and consider me favorable for the post I have applied for, & if selected I will try my best to render my services to the entire organization of yours to the fullest extent possible.

Thanking you,
Regards,

(SHAH CHAINESH N.)

CURRICULUM VITAE :
SHAH CHAINESH NARENDRABHAI, (M. Pharm- Pharmaceutics & MBA (DL)- HR)
E-mail : chainesh_26 AT yahoo.com

- DATE OF BIRTH : 26thjuly, 1986.
- MARRIATAL STATUS : Unmarried
- NATIONALITY : Indian
- LANGUAGES KNOWN : English, Gujarati, Hindi,tamil.
- FAMILY’S PROFILE : two member family
- EXTRA CURRICULAR ACTIVITIES : Hobbies: Traveling, Music listening, Reading Magazines, Newspapers.
Sports : Cricket, Bad Minton, Volley Ball

Degree/ Examination Percentage Institution /Board/University Year of passing Remarks :
MBA in HR (Distance mode) 57%
(up to 3rd semester) Madurai Kamraj University
(Centre- Vadodara) 2010-2012 Last 4thsemproject completed and result awaited.
M. Pharm (Pharmaceutics) 70.13 %
(1st year) Sumandeep Vidyapeeth University, Piparia, Vadodara, Gujarat, India. 2010-1012 2nd year perusing. Project completed. Thesis submitted and NOC issued by college.
Office Automation Course (Computer basic for office work) A-Grade M-Tech Computer Academy, Dabhoi, Vadodara, Gujarat, India. 2009 Computer hardware and software training centre.
B. Pharm 71.93% KMCH college of pharmacy, Coimbatore, Tamilnadu, India. 2006-2009 Dr. M.G.R. Medical university, Chennai
D. Pharm 55.00% Oxford Iinstitute of Pharmacy, Bangalore, Karnataka, India 2003-2005 Drug control board of Karnataka, Bangalore.
HSC 47.37% R.P.T.P. Higher Secondary School,
V. V. Nagar, Gujarat, India. 2003 GHSEB

M. PHARMA PROJECT :
Aim and Objective of My Thesis : atorvastatin is BCS class-2 drug used in the treatment of dyslipidemia. It is having major hurdle of limited bioavailability (12%) due to high first pass metabolism. The floating microsphere of atorvastatin may improve solubility and higher dissolution rate by decreasing particle size increasing surface area. Thus increasing patient compliance by significantly enhancement in oral bioavailability of the drug.

MBA PROJECT :
Aim and Objective of My Thesis : Today. In every organization training and development as an activity is necessary. It is vital ingredient for the success of the organization in long run. It is require examining the need and assessment of training, impact of training, behavioral changes due to training and differential change in output.

B. PHARMA PROJECT :
Aim and Objective of My Thesis : To Evaluate the physical parameters, alcohol content, total solid content, total microbial count of some of the marketed ayurvedic formulations of Dasamoolarista as per the pharmacopoeia. The present investigation found to contain above the acceptable range of microbial load in leading brands of Dasamoolarista. Regulatory agencies and government sector should implement stringent policies over the manufacture as well as marketing of herbal formulations.
Publication :
- The M. Pharm project entitled “Formulation and Characterization Of Gastro Retentive Floating Microspheres Of Atorvastatin” published In International Journal of Pharmacy Research & Technology 2012, Volume 2, Issue 1, 23-27.
- The B. Pharm project entitled “Quality control assessment of marketed brand of dasamoolarista – an ayurvedic formulation” Published in IJAR, March’2010.
Publications as a co-author :
- The M. Pharm project entitled “Formulation and Evaluation of sustained release bilayer tablet of Metformin Hcl and Pioglitazone” published In World journal of pharmaceutical research 2012.
- The M. Pharm project entitled “Dissolution enhancement of poorly soluble aceclofenac by using Beta- cyclodextrin” published In World journal of pharmaceutical research 2012.

Poster Presented :
- I Had presented poster at sigma institute of pharmacy, bakrol in PHARMAESCAPADE-2011 AND FOURTH COVENTION OF SOCIETY OF PHARMACOGNOSY on 14 th oct,2011 on floating microsphere.
- I Had presented poster at sigma institute of pharmacy,bakrol in PHARMAESCAPADE-2010 on 6th oct,2010 on diclofenacnanogel.and awarded 2nd rank among all poster presentation.
- I had presented poster at Baroda college of pharmacy &parul institute of pharmacy in PHARMAFEST’ 11 ON 19 & 20 FEB,2011 on liposome drug delivery system.

Seminar attended :
- I had attended national seminar on THE ART OF SCINTIFIC WRITING on 25th and 26th aprol,2008.

Extracurricular Activities :
- I stood player of the tournament award in cricket in B. Pharmacollege in MEDIFEST 2007.
- I was sports organizer and cricket team captain in B.Pharm final year in state level pharmacy intercollege tournament in P.S.G. college of pharmacy and same in D. Pharm during sports even

Declaration :
I am here by declaring that above information provided is true to best of my knowledge.

Date : 19-04-20112 (VADODARA) . SHAH CHAINESH N.

[Unregistered]

Curricular Vitae
Atiq Beg (ckb)
atiqbeg20 AT gmail.com
Lucknow, Utter Pradesh-226020 Bangalore-90

Career objective :
- Seeking for an opportunity to work with an organization that will provide a platform to utilize my technical skills and enrich my knowledge to help in the process of organizational.

Key Skills :
- Basic in computer
- Application : MS-Office.
- Electrical Skill : Control System, Electric Machine

Work Experience :
Cooling Centre (Shop no 93, Manni Mountra, Complex near S.G.P.G.I , Raebareli Road Lucknow) Work at Refrigeration & Air conditioning mechanics From June 2007 to June 2009

Education Details :
S. no Qualification Specialization Board/University Year Marks :
1 High School --- U.P State Board 2005 53.83%
2 Intermediate --- U.P State Board 2007 50%
3 B.E EEE VTU Karnataka 2013 48.43%

Declaration :
I hereby declare that the details provided above are true according to my best knowledge.

Signature- Your faithfully,
Date- Atiq Beg