Regulatory executive Resume

Experience

Over all + Year’s Experience in Drug Regulatory Affairs. A Regulatory professional with experience more than years in the reputed pharmaceuticals industries both in factory and corporate level. Dedicated to maintaining quality standards. Able to work on own initiative and as part of a team.

Professional Qualification

Bachelor of Pharmacy from Lloyd Institute of Management & Technology (Greater Noida) approved by Uttar Pradesh Technical University & PCI with Aggregate %.

Academic Qualification

: Matriculation from U.P. Board with . % in .                                 

• : Intermediate from U.P. Board with . % in .


•  

Present employer

Health Biotech Limited. Chandigarh (Haryana), A WHO-GMP Certified Company from July to till Date.

Designation                             

Executive-RA (Drug Regulatory Affair Department)

Past Experience

Alchon Parental (India) Limited Bhiwadi (Rajasthan) From August to June as an RA Executive. Ahlcon Parenterals (India) Ltd. has achieved the Quality Certification WHO-GMP International and ISO :. Manufacturing Intravenous Fluids & Eye/Ear Drops by highly sophisticated Manufacturing process, From – Fill-Seal Tech, having annually strong turnover about crore.

Gracure Pharmaceticals Limited Bhiwadi (Rajasthan) From Aug to August as an RA Executive. A WHO-GMP, EU-GMP and ISO : Certified Company. Gracure Pharmaceuticals Limited has two plants, another one is situated at Nalagarh (H.P.). It has near about crore turnover annually and have well market inEurope and Russian countries. The Gracure Pharmaceuticals Limited is now an EU-GMP certified company having strong market Globally.

Summer Training

Job profile      

:

:

Add:B-, Sector- Noida

Pin (India)

Duration: -- to --

Handling over all Dossier work and related document as per with CTD and ACTD.

Preparation of Dossiers as per ACTD , CTD Guidelines & CIS countries

Mainly for following countries:

-Vietnam, Singapore, Indonesia,Myanmar.

-Kenya, Trinidad, Tajikistan, Taiwan, Sudan.

-Nigeria, Thailand, Ukraine, Uzbekistan,Tanzania.

-Greece, Turkmenistan, Philippines, Mission,Venezuela and South

 Africa   etc.

Preparation and review of query (dossier) response.

Maintaining Regulatory documents as per the procedure.

Reviewing of DMF & Preparation of COPP,FSC, NOC and registration

file for New drug

Instrument Handle

:

Inspection Phases

:

IT Skills                                  

:

MS office, Network Knowledge with Internet.

Ms Office--

Win/XP//

Personal profile       

Father Name     :     Shri Rajendra Singh

Mother Name    :     Smt Lajjawati

D.O.B               :     ^th November

Marital status    :     Unmarried

Gender             :     Female

Permanent Add.:     Post-Moholla Pathak

                                New Basti  Jahangeerabad

                                Bulandshaher U.P.

                                Pin-

Present Salary

:

. Lac per annum CTC

Expected salary

:

Negotiable