www.magnumconsultants.com Magnum Consultants Bangalore : Regulatory Affairs Executive

[muthukalee]

Magnum Consultants Whitefield : Regulatory Affairs Executive- EU & ROW

Company Name : Magnum Consultants
Company Location : Whitefield
Designation (of vacancy) : Regulatory Affairs Executive- EU & ROW
Company E-mail ID : sharli@magnumconsultants.com
Company Website : www.magnumconsultants.com

Job Description, Candidate Profile, Company Profile, Company Address :

Hi,

Greetings from MAGNUM CONSULTANTS!!!!!

We have an Exciting opportunity for Executive Regulatory Affairs position with a well known Pharmaceutical Company in Bangalore.

Please go through the following -Regarding MAGNUM bestowed for you.

Summary
Designation : Executive Regulatory Affairs
Experience : 2-8 years
Location : Bangalore
Salary : Best in the Industry/ Hike will be given on your current CTC
Positions : 2 - Europe Market,
Positions : 2 Rest of the world

Job Responsibilities :
• Compilation , quality review and submission of registration dossiers in CTD format for regulated markets (UK) and semi regulated countries ( CIS )
• Assess documentation to ensure compliance to necessary guidelines
• Trouble shooter to queries from ministries and customers to expedite the approval process
• Interact with other departments to discuss and provide solutions to regulatory issues and/or problems & communicate with suppliers to request and/or provide data relevant to submissions.
• Perform Gap analysis, review of documents like BMR BPR, Specifications, Stability data and analytical method validations
• Co-ordination with concerned department to arrange samples for regulatory submissions.
• Compiling and submission of dossiers to various regulated Rest of the world (ROW) (EU) as well as semi regulated markets in CTD format. Handled various finished Product formulations
• Attending queries from various agencies.
• Establishing of better co-ordination with various departments of Pharmaceutical industry.

Requirements :
• Excellent working knowledge of computers, e-mail etc.
• Possess Good Communication Skills, Energetic, Hardworking and Committed.
• Ability to work in teams.
• Ability to interact with people at various levels in the organization.

Interested Candidate can fill the below & Revert back with the Updated CV Immediately

Name
Position
Current Location
Current Company
Current Designation
Experience
Current CTC
Expected CTC
Notice Period.
Reason for job change
Education

Forward to your friends & relatives one who is interested.

Regards
Sharli
Call : 41492100 (9.30 am-6.00 pm) or mail me sharli@magnumconsultants.com

Contact us :
Magnum Consultants
#3/3,3rd Floor, RT Plaza,
80 Feet Road, RT Nagar,
Bangalore-560032
Phone : 91-80-4149 2003/2004/2100

[yashtej007]

Dear sir,
Kindly find the attached resume for any suitable position in esteemed Pharma organization.
Myself, Shantiprasad B. Babhale.
EXPERIENCE: 1 year 1 month
COMPANY :CIPLA GOA
DESIGNATION : QA OFFICER
AREA OF INTEREST : REGULATORY AFFAIRS , QA

Thanks & Regards,
S.B. BABHALE


Email : yashtej007@yahoo.co.in
Mob :

[Rahulthakur]

RAHUL A. THAKUR

Email : rahulthakur50371 AT gmail.com

OBJECTIVE
To be a successful person by using full depth of my knowledge and skill; thus implementing all for the cause of growth of the company.
AREAS OF INTEREST
Data Mining, Database management, IPR, Regulatory affairs, Bioinformatics, Chemoinformatics, Computer Aided Drug Design and Software development.
ACADEMIC RESEARCH PROJECTS
Design of liver selective glucokinase activators : Pharmacophore mapping, Virtual screening and Molecular docking.
This work is on designing the glucokinase activators by structure based query generation then pharmacophore mapping. Using the pharmacophore map, screening of large databases is carried out and docking analysis of the hits retrieved.

ACADEMIC PROFILE

Qualification Year %/CGPA School/College University/board
M. S. (Pharm.)
Pharmacoinformatics To be completed in June 2011 6.23/10
(up to IInd sem.) National Institute of Pharmaceutical Education and Research NIPER, S. A. S. Nagar, Punjab
B. Pharmacy 2005-2008 62.04% Institute of Pharmaceutical Education and Research,
Wardha R. T. M. Nagpur University, Nagpur
H. S. C. 2003 59.00% U.N.H.S
Nagpur Nagpur Board, Maharashtra
S. S. C. 2001 65.06% Golden kids high school
Amravati Pune Board, Maharashtra


KEY TECHNICAL SKILLS
- Data Mining/Statistics software used : Sigmastat, Sigmaplot.
- Programing/Scripting skills : C++, Perl.
- Hardware and operating systems worked on : SGI Tezro, Windows and LINUX.
- Chem-Bio software used : Tripos Sybyl (FlexX, Unity), Accelrys Discovery Studio2.0 (Query generation), Schrodinger Maestro 9.0.21 (Glide), AutoDock4.0, PyMOL.
- Other software used : MS Access, M.S. Excel, Endnote, Visual studio 2005, Open babel, X-manager etc.
ACADEMIC ACHIEVEMENTS
- Secured All India Rank 1071 with 95.51 percentile in GATE 2009 (Pharmaceutical Sciences) conducted by IIT Roorkee.
- Secured All India Rank 215 in NIPER-JEE-2009 conducted by NIPER, Mohali.
TRAINING/WORKSHOP
- Persuing course on Clinical Data management (Oracle) and SAS programming at NIPER.
- Persuing distance learning course on, Industry Program in Pharma Regulatory Affairs (1 year) at Bioinformatics Institute of India, Noida.
- General course on IPR from WIPO, Geneva, through distance learning program, 2010.
EXTRA-CURRICULARS
- Attended “Drug Metabolism and Pharmacokinetics, Symposium 2010” at NIPER, S. A. S. Nagar, Feb, 2010.
- Attended “IPR in Biomedical Research, Symposium 2010” at PGIMER, Chandigarh.
- Participated in cricket, chess, badminton and volleyball in school and B-pharm.

[Guest]

DHIVYA TAMIL. A
Email Id : dhivya .tamil AT gmail.com
Objective
To utilize my talent and ability to work in a highly competitive environment that can provide me great chance to excel knowledge and ample opportunity.
Work Experience
Presently working as Regulatory Affair Associate (North America –Operation) at VWR Lab Products Pvt. Ltd (A Group of VWR International-LLC), since 30th May 2010.
Work Nature :
- Enrolled under the North American Fedral Government Regualtory Affairs Laws and Acts
- Acquisition of documents (Licenses) for Controlled substances & RX-Lablled Products.
- Supporting Enviornmental health safety (EHS) data validation.
- Genarating the private lablled certificates for the VWR products as a adherent to Quality Assurance ( QA) department.
- Handling and updating the MSDS for VWR products
- Performed as dynamic Team Training SPOC
Project
- Completed Degree project on the basis of DNA Fingerprinting in the Institute Of Forest genetics And Tree breeding – Coimbatore (IFGTB) on the Topic Identification of the Dihybrid E.tereticornis x E.alba using RAPD Assay.
- Completed Mini project In Flora Agro Biotech Research Centre – Coimbatore on the topic Micropropagation.
Educational qualification
Graduation Level (2005- 2009 )
Bachelors B.Tech.,Biotechnology at Anna University, Chennai, India
Percentage 81
Main Modules Studied Genetics, DNA technology, New Drug Development, Chemical Engineering, Thermodynamics.
Academics (2003-2005)
H S C Alvernia Convent, Coimbatore, India
Percentage 87.33
Academics (2002-2003)
S S L C Alvernia Convent, Coimbatore, India
Percentage 80.73
Paper Presented :
Submitted paper in national level seminar
TOPIC :
Cyanide Determination in Plants by Picrate and Acid Hydrolysis Method –
A Comparative study
VENUE :
- Government College Of Technology- Coimbatore
- K.S.R College Of Technology And Engineering- Tiruchengodu
Achievements
- Won 2nd prize on my paper presentation in national level seminar held at K.S.R College Of Technology And Engineering- Tiruchengodu
- Secured high percentage score in BIOPROCESS ENGINEERING (91%) paper and lab section during my academic B.Tech graduation.
- Secured district rank in Biology in HSC examination
Professional Membership
- Indian society for technical education
- Active member in NSS camp
- Elected as secretary in the Department of Biotechnology during my academic.
Software Profile
- Operating Systems : Windows 2000, Windows Microsoft XP.
- Language : C , C++ (basics)
- Tool Used : ESS (Enviornmental Support Solution)
Laboratory Experience :
Worked as trainee in the Institute of forest genetics and tree breeding – Coimbatore under Department of Biotechnology for the period of June 2009- February 2010
Attempts
Appeared for national level exam “Graduate for Science – GS2010” held at Indian Institute of Technology Chennai on December 13th 2009.

[Guest]

Dear Sir/Madam
I am a Post-graduate of Life Science, specialized in Biochemistry, from Bangalore University, Bangalore
I enclose my Curriculum Vitae as a first step in exploring the possibilities of joining your organization.
I look forward for an opportunity to interact with you for the same.
Awaiting an early response and future association with your esteemed organization.

Thanking you

Soujanya.A.Mahale

CURRICULUM VITAE
Soujanya.A.Mahale E-mail : soujanya.mahale AT gmail.com
soujanya_mahale2000 AT yahoo.com

Career Objective :
Seeking a responsible and career oriented opportunity to use my knowledge for the growth of a company. Also willing to become an important asset of the company where I can utilize my skills and abilities in the Pharmaceutical Industry that offers professional growth while being resourceful, innovative and flexible.
Educational Details
M,Sc Biochemistry –Garden City College,Bangalore
B.Sc Biotechnology –Maharani Ammani College For Women , Bangalore
Additional Information
Sound understanding of Pharmaceutical & International markets.
Understanding of therapeutic areas.
Personal strengths :
Organized Task Manager, Logical thinker
.
Entrepreneurial drive, Professional commitment.

CORPORATE EXPOSURE
1. BIOCON LIMITED
Working as a Regulatory Affairs Executive in International Division Biological Formulations at Biocon Limited Hosur Road Bangalore, from August 2010 till date
ROLES AND RESPONSIBILITIES
o Dossier preparation and filing.= For Insulin and its Analogs, Streptokinase
o Query handing.
o Tender Participations
JOB PROFILE :
1. Compile, prepare, review and submit regulatory submission to authorities for
a. Semi regulated Markets :
Thailand, Malaysia, Philippines
b. ROW Markets :
Tanzania, Zimbabwe, Namibia, Kyrgyzstan, Morocco, Ethiopia, Kenya, Benin, etc…
2. MICRO LABS LIMITED, BANGALORE
Experience in Regulatory Affairs
Working as a Regulatory Affairs Executive in Exports Division at Micro labs Limited Bangalore from November 2008 to July 2010
ROLES AND RESPONSIBILITIES
o Dossier preparation and filing.
o Query handing.
o Documentation as per different countries.
o Coordination with contract Clinical Research Service Center, Marketing & R&D teams.

JOB PROFILE :
2. Compile, prepare, review and submit regulatory submission to authorities for
a. Semi regulated Markets :
Thailand, Malaysia, Philippines, Russia,
b. ROW Markets :
Kenya, Ukraine, Uganda, Ivory Coast, Senegal, Nigeria, Cameroon, Kazakhstan, Uzbek, Srilanka.
3. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
4. Monitor impact of changing regulations on submission strategies
5. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
6. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
7. Communicate and network with scientific and regulatory personnel to obtain relevant information
8. Translate and communicate technical regulatory issues for nontechnical audiences Research, analyze, integrate and organize background information from diverse sources
3. MEDREICH LIMITED ,BANGALORE
Medreich is an integrated technology driven healthcare company. The company has grown rapidly over the last decade. In 2006, its estimated revenue is US$ 90 million spread over diverse business profiles including own marketing in various geographies, strategic alliances with giants like GlaxoSmithKline, Pfizer, Sanofi aventis, Wyeth and Adcock ingram and formulation development activity.
Experience in Regulatory Affairs
Worked as a Regulatory Officer in Medreich Limited, Bangalore from January 2008 till November 2008

The responsibilities included in Regulatory Affairs
Domestic RA
- Preparing submissions of licence and renewals
- setting timelines for licence variations and renewal approvals
- keeping up to date with a company's product range
- Handling Queries from DCGI and Karnataka Drugs Control
- Applying for Tenders
- Arranging for GMP Audits
Regulatory Guidelines Efficiency
- BP
- USP
- IP
Exports :
Compiling Re- registration Dossiers foe Sudan, Yemen, Uganda
Project Work :
“Clinical Biochemistry” at Canara Diagnostic Laboratory, Honavar.

“Recombinant DNA Technology” at EDUBIOTECH, Bangalore
“Plant Tissue Culture”.
“Interleukins” under the guidance of Prof. Geetha Mishra
Personal details
Date of Birth : 3rd March 1985
Sex :
Marital status : Married
Languages Known : English, Hindi ,Kannada and Kokani
Hobbies : Painting

EXPERIENCES
Training Experience
Worked as a Quality control trainee for a period of 3 Weeks at Micro Labs , Sipcot Industrial Area, Bangalore
EXTRA CURRICULAR ACTIVITIES
Won I Prize at District level, in National Level Chintana Science Exam.
Scored 81% marks in Vedic Ganita Adhyayana Vedike(Part 1).
Participated in various workshops conducted by different colleges.
Attended various Symposiums held at IIC.
Organized events at Departmental level.
Participated in conducting Management Fest, BioEnigmain 2004 &2005.
Strengths
Hard working, self-motivated and leadership qualities.
Areas of Special Interest
Regulatory Affairs, Drug safety Monitoring, Quality Assurances, Clinical Trials

[Guest]

CURRICULAM VITAE
ISAQ AHMAD BAGWAN
Isaq88 AT gmail.com

Seeking to handle increasing responsibility and challenging assignments that integrate my skill and knowledge.
Philosophy of life-hardwork is key to success

Course Name of University Subject Year of Passing Percentage
Msc
Bangalore University Microbiology 2008 65.4%
Bsc
Karnataka University Dharwad Chemistry Botany Zoology 2006 64.6%

A : Immunological techniques:
- Slide agglutination test
- Precipitation test
- Elisa test

B : Medical Techniques:
- Isolation & Characterization of clinical important microorganism
- Drug susceptibility test
C : Microbiological techniques:
- Staining Techniques & Biochemical Test


Effect of beet leaves and clove oil on Pseudomonas.Staphylococcus aures & candida albicans In sangene biotech pharma Bangalore

- Experience in teaching at Halamma Institute of Paramedical Course, ILKAL
- Experience in aqua nice mineral water for six month
- Working as Microbiologist in EHS R & D Center from January 2010 to till date.
- Analysing Total Coli form, Faecal Coliform, streptococcus, staphylococcus, and salmonella, organisms in potable and waste water.
- Analysis of physical parameters like pH, Conductivity, Total Dissolved Solids, Total Suspended Solids, Turbidity.
- Analysis of Chemical parameters like Chloride, Sulphate, Total hardness, Total alkalinity, Fluoride, Calcium, Magnesium, Nitrate, Iron, Chemical Oxygen Demand, Biochemical Oxygen Demand, Boron.
- Analysis of heavy metals (Cu, Fe, As, Hg, Zn etc.,) in air, soil and water samples by Atomic Absorption Spectrophotometric (AAS) method