Manager Pharmaceutical

Official Address:

Apeejay Stya House,

**, ****** ****, **-*

New Delhi-110048

Suman

Current Location: New Delhi

Residential Address:

***-***** *********,

Fatehpur Beri,

New Delhi-110074.

Email: yswdz7@r.postjobfree.com

Phone Number: +91-991*******

OBJECTIVE: To achieve a challenging position in Pharmaceutical Industry and be a part of a team that dynamically works for the growth of the organization.

SUMMARY OF EXPERTISE:

MEDICO-REGULATORY:

Filings (Domestic market-India):

• New Drug Filings & Dossier compilation

• Filing of Clinical Trial (CT) and Bioequivalence (BE) Applications.

• Filing of Import Permission, Product and Plant Registration and Import License.

• Co-ordination with various internal stakeholders like R&D, QA, Production & Packaging

• Extension of Shelf Life Application.

• Clinical trial registration with CTRI

• Preparing documents and co-ordination with respective committees for ethical committee approval.

Scientific Data Review and Regulatory Inputs:

• Review of Specification and Stability Protocols

• Co-ordination with other departments like production, R&D, QC

• Review & Approval of label and Prescribing Information

• Interactions and answering Queries of Regulators from the O/o DCG(I)

• Preparation and review of clinical trial reports

• Tracking of new Regulatory Guidelines and their updates

Customer Complaints

• Quality Related

• Regulatory Inputs on Medical Complaint

Ensuring Pharmacopoeial Compliance of marketed Products

PROFESSIONAL EXPERIENCE: 1.5 yr

Exact Title of Position held: Asst. Manager, Medico-Regulatory affairs

From:-To: 09/2010 – Till date

Name and title of supervisor(s): Dr. Manju Purohit (Head, Medico-Regulatory affairs Dept.)

Name/address of employer: Walter Bushnell Pvt. Ltd.,

Apeejay Stya House 14, Commercial Complex, Masjid Moth Greater Kailash - II, New Delhi-110048

ACADEMIC PROFILE:

2010 M.Pharm Delhi Institute of Pharmaceutical Sciences and Research

Department of pharmaceutics, Delhi University

Aggregate-75.3%

2008 B.Pharm Delhi Institute of Pharmaceutical Sciences and Research

Delhi University

Overall aggregate-75.0%

2008 Graduate aptitude test in

engineering (GATE)

Major in Pharmaceutical Sciences

Percentile-97.99

2004 Intermediate (10+2) Navayug School, New Delhi

Central board of Secondary Education

Aggregate-85.16%

2002 Matriculation (10th) Navayug School, New Delhi

Central board of Secondary Education

Aggregate-87.4%

PUBLICATIONS:

• "Asymmetric membrane capsules: New prospects in osmotic drug delivery", International Journal of drug delivery 2011; 3(2): 185-193.

• "Osmotically controlled oral delivery of Ciprofloxacin through asymmetric membrane

capsules", communicated in Drug development and industrial pharmacy, ID No: LDDI-2011-0345.

ACHIEVEMENTS, CERTIFICATIONS & AWARDS:

• Recipient of Second Prize and Certificate of Merit in M.Pharm Part-1, at DIPSAR, New Delhi.

• Recipient of Second Prize and Certificate of Merit in B.Pharm by Delhi Pharmacy Council in 47th National Pharmacy week 2008.

• Recipient of Second Prize and Certificate of Merit in B.Pharm, at DIPSAR, New Delhi.

• Successfully completed General course on Intellectual Property Rights, World Intellectual Property Organization,(WIPO),2010,with a grade of 89%.

• Pursuing Post Graduate Diploma in Intellectual Property Rights (PGDIPR), from IGNOU (Delhi).

• Life member, Indian Pharmaceutical Graduates Association (IPGA).

• Registered Pharmacist with Delhi Pharmacy council, registration no.: 19059.

CONFERENCES ATTENDED:

• Actively participated as a delegate in All India Food Safety Summit-2011 organized by All Inida Food processors Association, New Delhi

• Volunteered in the 39th Annual conference of “Indian Pharmaceutical Association” 2009, DIPSAR, New Delhi

• Attended a national symposium on “Translational Research in Health Sciences” 2009 organised by Society of Young Scientists, AIIMS , New Delhi

• Actively participated as a delegate in National Seminar on “Innovations in Novel Drug Delivery Systems” 2009, Organised by Ram Gopal College of Pharmacy, Gurgaon.

• Actively participated as a volunteer in 3rd and 4th Global Conference on “Recent Advances In Cardiovascular Sciences”, DIPSAR, New Delhi.

• Actively participated as a volunteer in 60th annual conference of “Indian pharmaceutical congress” 2008, NSIT, New Delhi

RESEARCH PROJECT/THESIS:

M.Pharm

Major objectives

COMPUTER PROFICIENCY:

• Microsoft operating systems and application software: MS Office.

• Scientific data retrieval from various Internet portals like Sciencedirect, Pubmed, Highwire Google Scholar, Rx List and Scirus etc.

• Technical software: Sigma Stat, etc

CO-CURRICULAR ACTIVITIES:

• Involved in the organizing committees of cultural programs.

• Actively participated in the National Pulse Polio Immunization Programme during graduation

• Actively participated and won many Prizes in Debate, Extempore, Painting Competitions, Assay writing, & many Cultural Events at School and Interschool level.

PERSONAL INFORMATION:

I hereby solemnly declare that all the information provided here is as per best of my knowledge.

Date: 2.02.2012

Place: New Delhi (Suman)

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