Drug Regulatory Affairs

Career Objectives

“To be associated with any organization which offer challenges and provide an opportunity for upward mobility and increased responsibility based upon merit and Performance”

ABOUT ME:

Drug Regulatory Affairs Professional with strong leadership skills having experience in the field of Intellectual Property Management and Commercialization of Technologies, DRA. Currently working with Mylan Laboratories Limited, Indore as Officer Drug Regulatory Affairs. I take pride in myself and my work, and derive considerable satisfaction from doing an assignment well. I cope well with high-stress situations and can manage a variety of projects simultaneously. Ability to work in stringent and challenging conditions and are able to work in a team or own if required. High personal integrity & have a good interpersonal skill. My specific proficiencies include excellent knowledge of patents, patent search tools (STN, DELPHION, DIALOGUE, MEDLINE, EPOQUE, DERWENT and M-CAM), Patent specification Drafting, USFDA, MHRA and other world drug regulatory agencies. Well-equipped with computer applications (MS Office, Excel etc.) and patent search tools

PROFESSIONAL EXPERIENCE

1. Working as Officer Drug regulatory affairs at Mylan Laboratories Limited, Indore, India

Job Responsibility:

a)Coordinate for state drug licensing activities, preparation & verification of licenses for finished drug products

b)Coordinate for central drug licensing activities, compile documentation for applying licenses to Indian FDA

c)To compile, review and share technical data for filing of followings:

i.New Projects of Canada/ US/ EU

ii.Site transfer projects of Canada/ US/ EU

iii.Regulatory annual reports for Canada/ US/ EU

iv.To compile review and share technical data for filing of post approval variations in Canada / US/ EU.

d)To ensure timely availability of technical inputs for clearance for product recipe, packaging recipe, artworks, stability protocols for Canada / US/ EU markets.

e)Review & approve technical documents like BMR/BPR/Stability protocols/ artworks.

f)Coordinate with different departments’ production, QA, QC, PDL etc.

g)Coordinate with corporate & Global RA, F&D, RnD, ADL, and Business Development.

2. Worked as Research Associate in Indian Institute of Natural Resin and Gums, Namkum in “Intellectual Property Management and Transfer/ Commercialization of Technology”

Job responsibility: Assisting the scientists working in different areas of Natural resins and gums with respect to the patent filing, patent search, technology transfer, IP management, and IP awareness, protection of plant varieties and commercialization, assisting staff for development of research projects & inventions regarding IP, conducting IP-related training for staffs.

Projects handled

Patent filing (Drafted patent specification)

Novel molecular method to differentiate infra-sub specific forms, Kusmi and Rangeeni, of Indian lac insect, Kerria lacca Patent app no. - 1333/KOL/2013

Inhibition of growth in human malignant cell lines using lac dye Patent app no. - 1435/KOL/2013

Filing of FER of patent application no. 580/KOL/2011 (Group specific primers for identification of Kerria species)

Technology transfer (MoU drafting)

Lac based natural Alta: - Preparation and composition for lac dye based natural skin colorant.

Conducted monthly IP awareness programme for the scientists working in different areas of natural resins and gums.

Successfully completed Institute (IINRG) sponsored 3 days training programme titled “Drafting and Processing of Patent Application” conducted by Rajiv Gandhi National institute of intellectual property management, Nagpur (RGNIIPM, Gov. of India) from 2nd -4th March 2015.

Represented institute in seminar on “Eastern Region Chapter on IPR in Agriculture” at ICAR Research complex for eastern region on 27th -28th Feb, 2014.

Organized Institute Industry Meet at Balrampur on 17th Jan 2014.

3. Worked as Trainee production Officer in the Mylan Laboratories Ltd Nasik Maharashtra from 1ST August 2012 till 25th April 2013. Selected through the Campus placement.

Job responsibility: To carry out the day to day manufacturing activity according to the SOPs with proper documentation and cGMP guidelines.

4. Worked as Sales Officer in Ordain health global Pvt. At Jamshedpur from June 2013 to Sep 2013

Job responsibility: Visit hospitals/ doctors clinic to promote product. Drive the sales initiative to achieve the desire targets. Build a strong relationship with doctors and stockiest. Monitor the stocks and supply of production.

5. Worked as medicine dispenser at a retail chemist shop from Jan 2005 to Dec 2005.

Job responsibility: dispensing of medications on the prescription of medical practitioners.

SKILLS & EXPERTISE

Conversant with ICH & FDA guidelines, regulation and applicable global and local standard operating procedures.

Well-versed with Schedule Y, cGMP, NDA, NDA regulations, Classification of drugs in NDA

Pharmacokinetics, Bioavailability, Concept related to BA/BE studies

Concept related to INDA, ANDA, ANDA filing Guidelines, Para I-IV filing.

Awareness of international regulatory authorities and filing, Hatch Waxman act, orange book.

Knowledge of IPR, Patent search, Patent management.

Concept related to Patent Filing, search engines like Delphion, & Questel`s Orbit Knowledge of search database like STN, DIALOGUE, MEDLINE, EPOQUE, DERWENT and M-CAM

Well equipped with data retrieval from different patent search sites e.g. www.ipindia.nic.in, www.patinfo.nic.in, www.indianpatents.org.in, www.uspto.gov/patft/index.html, http://ep.espacenet.com, http://www.wipo.int etc.

EDUCATIONAL PROFILE

SNo.

Description

Board/ University

Year

Remarks

1

*M.Pharm

BIT Mesra, Ranchi

2012

8.15(10 point scale)

2

Diploma in Intellectual Property Laws

BVDU- Pune

2012

64.5%

2

B. Pharm.

BIT Mesra, Ranchi

2010

74.9%

3

12th

AMU Board

2004

65.75%

4

10th

C.B.S.E

2002

88.2%

*Specialization in pharmaceutics: “Development of Gastro-retentive floating tablets of Clarithromycin and famotidine for effective treatment of H.pylori mediated gastric ulcer.

Work description: preparation of Tablets containing Clarithromycin & Famotidine; using Gellan gum And HPMC K4M as controlled releasing & floating polymers.” under the supervision of Prof. (Mrs.) S. G. Panpalia

PG DIPLOMA COURSES

Successfully completed one year Post Graduate Diploma Course in Intellectual Property Rights from New Law College, (SDE) Bharati Vidyapeeth Deemed University, Pune.

COMPUTER PROFICIENCY

Windows operating systems and application software: Windows XP, MS (Word, Excel & PowerPoint)

Data retrieval from various internet portals like Science direct, Google scholar etc.

Typing and transcription accuracy

SEMINARS DELIVERED

Seminar delivered on the Hatch Waxman act and its impact on drug development process.

Pharmacist and healthcare profession.

Poster presentation in National symposium on Recent Advances in Beneficial Insects held at IINRG Namkum 27-29 Nov 2013

Lecture on “Our representation in the field of medical sciences” in the Education Development Seminar (eastern region) Islamic Development Banks (Jeddah) scholarships program, on 06.06.2014 in Ranchi, India

ACHIEVEMENTS & EXTRA CURRICULAR ACTIVITIES

Scholar of Islamic Development Bank (IDB) (Jeddah) for UG & PG courses

Active member of All India IDB Graduate Association.

GPAT-2010 qualified examination conducted by AICTE and M.S. University with All India Rank 2700.

Active member of Pharmaceutical Society at BIT Mesra Jharkhand branch from 2006 to till date. Ranchi Jharkhand.

Sports skills: Basketball, Volleyball, football& Hockey at Institute level. Played East zone Hockey tournament, Institute Captain of Hockey Team of BIT Mesra in 2009-10.

NCC Camps: Attended two NCC Camps as NCC Cadet.

Team captain of college team in “Pharmaceutical Aura Celebrating Euphorbia”(PACE-2008) annual Pharma fest held at BIT Mesra in February 2008 Participated in various Cultural events: and got prizes in Poetry, Tyro, Skit, Mystiques

WORKSHOPS/ CONFERENCE ATTENDED

Participated in Seminar and exhibition for display/demonstration in “Advantage Jharkhand – Food Processing Investors Summit 2015” which was held on April 23-24, 2015 at Khel-Gaon, Ranchi.

Nominated by institute to attend the workshop on “Relevance and importance of intellectual property rights” on 20th November, 2014 organized by Jharkhand silk textile and handicraft development corporation Ltd.

Attended a seminar on “Intellectual Property and Innovation Management in Knowledge Era” Organized by NDRC & BIT, Mesra on 21st February, 2012.

Attained workshop on Intellectual Property Rights(IPR)December 02, 2011 at BIT Mesra Sponsored by Controller General of Patents, Design & Trade Marks, Govt. of India

Participated in Poster presentation at “International Conference on Recent Advances in Pharmaceutical Sciences” December 22nd-23rd, 2010” organized by Department Of Pharmaceutics, IT–BHU, Varanasi.

PERSONAL VITAE

Date of Birth 7th October 1986

Linguistic Abilities: English, Hindi, Urdu, Oriya, Arabic (Read)

Permanent Address: Ali bagh Jesu Bhawan old Purulia road mango Jamshedpur Jharkhand, India- 832110

DECLARATION

I hereby declare that all the entries are correct to the best of my knowledge. If chance is given to me, I assure you that, I will prove myself as an asset for global research.

Yours sincerely

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