CURRICULUM VITAE

SANJIV KUMAR VERMA Contact no.: 08826822619Email id: sanjupharma2005@gmail.com

OBJECTIVE:

A strong motivation skill along with strong desire to work in the organization that matches my profile by constant learning and implementing. Looking forward for challenging career to prove myself with continuous hard work in the provided area of development

SUMMARY:

Having experience in FMCG and Drug registration in India and International markets. Experience in preparation, review, submission of registration document/dossier for registration in India and International markets based on CTD/ACTD/Country Specific Dossier format and as per country specific requirements. Key knowledge areas are as follows-

Registration of Food/ Food Supplements, Health supplements, Nutraceuticals, ingredients and additives in India

Registration of Pharmaceuticals (IND, Generics, OTC) in India & International markets.

Registration of Ayurvedic medicines in India. Registration of Cosmetics in India and in International Markets. Well versed with Drugs and Cosmetics Act 1940 and Rules 1945 and FSSR Act

2006 and Rules 2011. Well versed with ICH guidelines, CTD & ACTD formats. Sound knowledge of “The Standards of Weights and Measures Act 1976”. Sound knowledge of Sanitary import in India

PROFESSIONAL EXPOSURE:

Organization: Regulatory Wisdom, Sector-3, Dwarka, New Delhi.Designation: Senior Scientific and Regulatory Affairs Associate Time Duration: 5th March 2013 – till date

JOB PROFILE:

Working as Team Leader, experience in handling multiple people at a time Experience in handling various project at a time

Well Coordinate with the various departments like Quality Assurance, Production, Research & Development and Marketing for timely submission of dossier to regulatory authority

Submission of the dossier and query response within time limit to the Regulatory Authority.

FOOD/FOOD SUPPLEMENTS/ NUTRACEUTICALS:

Experience in FSSAI application processing and Liaison. Preparation, review, submission of registration documents for product approval of

food/food supplements, Health supplements, Nutraceuticals, Additives and Ingredients.

Preparation, review, submission of registration documents for scientific panel of food/food supplements, Health supplements, Additives and Ingredients.

Prepare word text of labels, Review and comments on labeling of food/food supplements, Health supplements, Nutraceuticals, Additives and Ingredients as per Food Safety Standard Act 2006 and Rules 2011(Packaging and Labeling Regulation, 2011).

Experience in providing product claims, health claims and nutrient claims of food, food supplements/ health supplements products so as to get competitive advantage.

Experience in regulatory assessment of formulation development in Food/ Food supplements, Health Supplements and Nutraceuticals.

Handling technical queries/deficiencies from regulatory authority (from Food Safety Standards Authority of India).

Experience in generating the standard specification of the product/ingredient to comply with specific monograph

Well coordinated with the various department like R & D, QA, QC for regulatory submission

Having International exposure in relation to the labeling requirement for the country specific (i.e. Australia, GCC Countries, Bangladesh, Sri-Lanka, Singapore, South Africa etc.)

DRUGS:

Handling technical queries/deficiencies from regulatory authority (from DCGI). New Drug, Generics and Import registration of Pharmaceuticals in India. Preparation and Review of Dossier in CTD and ACTD format Guidance providing in generation of standard specification and specific documents

of the product to comply with specific monograph and regulatory requirements. Review of label of Drugs and Cosmetics as per guidelines of Drugs and Cosmetics

Act 1940 and Rules 1945 and country specific requirements. Experience in conversion of prescription drugs to nonprescription drugs (OTC drugs)

with preparation of backed documents. Experience in providing product claims for Ayurvedic drugs and Herbal products

backed with scientific literature so as to get competitive advantage.

Preparation and Review of Dossier for the Ayurvedic Products Having experience in to decide the regulatory pathway for country specific

guidelines for Modern Drug, Herbal Drug and Cosmetics.

COSMETICS:

Import registration of cosmetic products in India Having International Exposure in Cosmetics dossier filling and Cosmetic

Notification to the different country i.e. Canada, ASEAN countries, Sri-Lanka and Some African Countries as per their specific requirements.

Label review of cosmetic products in compliance to Drugs and cosmetics Act 1940 and Rules 1945 and also in compliance to International Regulation

Exam passedSchool/ College Board/

UniversityYear of Passing

% of Marks

M.Pharm, (Pharmaceutics)

R.K.G.I.T.Ghaziabad, U.P.

M.T.U. 2012

68.5%

B.Pharm. B.B.D.N.I.T.M, Lucknow, U.P. U.P.T.U. 2009 68.78%

12th Children College Azamgarh, U.P. U.P. Board 1999 63.60%.

10th Children College Azamgarh, U.P. U.P. Board 1997 76%

PROJECT TITLE (M.PHARM -PHARMACEUTICS):

“Study on the Pluronic Lecithin Microemulsion based Organogel of Diacerein for topical delivery”.

SEMINAR AND WORKSHOPS ATTENDED & EXTRA ACTIVITY:

GPAT qualified in 2010 Participated in AICTE sponsored national seminar on “Academia- Industry Interface

in Pharmaceutical sector” in R.K.G.I.T. Ghaziabad U.P.

Participated in industrial visit organized by college BLUE CROSS LABORATORIES LTD. VERNA, GOA ABBOT INDIA LTD., GOA

KEY SKILLS:

Familiar with computer software like MS office tools, Excel, windows with basic Internet knowledge and power point.

EDUCATIONAL QUALIFICATIONS:

INDUSTRIAL TRAINING :

STRENGTHS:

I assess myself as hard working, confident, adaptive & sincere towards duty, devotion & discipline. PERSONAL INFORMATION:

Father’s Name : Shri Haricharan Prasad VermaMother’s Name : Smt. Girija DeviDate of Birth :  19 August 1983Gender :  MaleMarital Status : Married Nationality : IndianLanguage Known : Hindi, EnglishReligion : HinduHobbies : Travelling, Making New FriendsPermanent Address : Village-Musepur (Verma Niwas), P.O.-Sadar,

Dist.-Azamgarh (U.P.), 276001

DECLARATION:

I certify that to the best of my knowledge & belief, this resume correctly describes me & my qualifications.

PLACE: Ghaziabad SANJIV KUMAR VERMA DATE-