Executive Management

From,

Local Address: Syed Mohsin Ali

Flat No. **6, 2nd floor, bldg. no. 4, Lily View SRA, 255 sharma estate, off, S.V Road, Jogeshwari (W),

Mumbai-400102.

Dear, Sir/Madam,

I am a pharmacy postgraduate (M.Pharm) in Pharmaceutical Chemistry with total regulatory experience of 4.5 years and currently employed with Glenmark Pharmaceutical Ltd., Mumbai as Executive Regulatory Affairs.

My experience includes Dossier preparation (ACTD, CTD/non CTD) as per MOH guidelines and its review for Indian & ROW countries (Asian, African, Latin American, Gulf, CIS). Preparation and compilation of regulatory documents for ROW market and Indian market like Form-44, Form-40, Form-30, Test Lic., Post Approval Changes submission to NRA, WHO GMP Certificate, CoPP, Export NOC, Import of Pharmaceutical products & API and their regulatory submission. Preparation of query reply to regulatory bodies and submission of post approval changes. Screening the technical documents for the grant of license to manufacture, marketing authorization or export of pharmaceutical products according to guidelines and permission for various regulatory purposes etc.

My aim is to build a career in Pharmaceutical Industry by learning various skills to explore newer dimensions in the frontier areas of Regulatory Affairs in particular.

I am willing to take up any new and challenging programme that can lead to better career prospects.

With my exposure to the Statutory Approval Procedures and guidelines, I am sure that I would be able to make a significant contribution to your company's regulatory team.

I am enclosing herewith my resume for your perusal and look forward to hear from you.

With kind regards,

(Syed Mohsin Ali)

SYED MOHSIN ALI

M.Pharm. (Pharmaceutical Chemistry)

Local Address:

Syed Mohsin Ali Email: ****************@*****.***

Flat No. 206, 2nd Floor Bldg No. 4, ********@*****.***

Lily View SRA, 255 Sharma Estate, Mobile No.: 075********

Off S.V Road, Jogeshwari (W), 099********

Mumbai-400102, Maharastra, India

CAREER OBJECTIVE:

An Opportunity to make worthwhile contribution to organization utilizing my technical, analytical skills gained so far and continuously upgrading the same for the development of the organization and self-improvement.

EDUCATIONAL QUALIFICATIONS:

S. No.

Qualification

Institute/University

Year of Passing

Percentage

1.

M. Pharma

J.S.S. College of Pharmacy, Mysore, India

April 2011

75.00%

2.

B. Pharm

J.S.S. College of Pharmacy, Mysore.

RGUHS, Bangalore, India

OCT 2008

67.04%

M. Pharm Research Project (2009 – 2011):

Project Title

SYNTHESIS AND IN-VITRO ANTICANCER ACTIVITY OF SOME NEW QUINAZOLINONE DERIVATIVES.

Specialization

Pharmaceutical Chemistry

PROFESSIONAL EXPERIENCE (4.5 Years):

S. No.

Department

Designation

Duration

Organization Name

1.

Regulatory Affairs

Executive Regulatory Affairs

April 2015 to at present

Glenmark Pharmaceutical Ltd., Mumbai, India

2.

Regulatory Affairs

Executive Regulatory Affairs

May 2013 - March 2015

Panacea Biotec Ltd., New Delhi, India

3.

Regulatory Affairs & QA

Technical Associate

June 2011-

April 2013

Central Drug Standard Control Organization (CDSCO, New Delhi, India) under DCGI.

CURRENT AND PREVIOUS JOB RESPONSIBILITIES:

A.For International Market (Biological, Injectable and other Pharmaceuticals dosage form):

Dossier preparation (ACTD, CTD/non CTD) as per regulatory guidelines and its review to get the marketing authorization in ROW countries (Asian, African, Latam American, Gulf, CIS).

Reviewing drug substance/drug product documents received from plant for dossier preparations.

Reviewing Package Insert, Artwork and approving same as per respective regulatory requirements and market supply.

Query response preparation in reference to product registration.

Review of Change controls forms.

Submission of variation/Post Approval changes to the regulatory bodies.

Co-ordination and follow up with R&D, QA & QC & others cross functional department.

Follow up with agents for registration of drug product in the country.

Knowledge of WHO/ICH guidelines.

B.For WHO/Unicef Market (Vaccines):

Preparation and submission of Product Summary File (PSF) in WHO Geneva, Switzerland to obtain WHO Pre-Qualification certificate for vaccines.

Preparation of regulatory documents of Annual Reporting submission in WHO for Pre-qualified vaccines (PQVAR).

Post Approval Changes submission to WHO for Pre-qualified vaccines.

C.For Indian Market (Pharmaceuticals, Biologicals, Cosmetics and Neutraceuticals Products):

Knowledge of schedules mentioned in D&C Act like Schedule Y, M etc.

Preparation, compilation & review of applications to process the regulatory submission in CDSCO/DCG(I) to get the Market authorization / New Drug Permission (Form-46 & 46A), Import Permission of New Drug Product & New Drug Substances in Form-45 & Form-45A. Registration Certificate to import drugs (Form 41), Import License (Form 10).

To develop, review and revise clinical study reports, investigator’s brochure and protocols of clinical trials.

Review of clinical trial protocol, CMC data and preparation of application/dossiers as per Regulatory Guidelines, GCP, GMP and schedule Y of D&C Act & Rule for submission to Regulatory Agency for CT Phase I, II & III permission.

Test License for import of drugs under Form 11, NOC for manufacturing of test batches for examination, test and analysis under Form 29.

Post Approval Changes submission (change control) to DCGI.

Submission of PMS, PSUR, AE’s & SAE’s to CDSCO in timely manner.

Preparation and submission of Product Permission Document (PPD), Summary of Product Characteristics (SmPC) and query response to NRA.

Preparation & submission of application for Export NOC, Import NOC, Form-29 NOC & CoPP in CDSCO zonal office.

Preparation, compilation & submission documents to State Licensing authority (SLA) for renewal of GMP certificate, renewal of manufacturing license, revalidation of CoPP, issuance of wholesale license, Free sale certificate & Form-29.

Regulation of drugs prices as per NPPA (DPCO).

Regulatory support in tender filling to legal and business department

Adapt working in New Product Development teams for regulatory support.

Documentation, Compilation & Data Management for Regulatory Filing.

PRACTICAL ON THE HAND EXPERIENCE:

Operation of FTIR spectrophotometer (Shimadzu 8400S)

Operation of Ultraviolet Visible Spectrophotometer (Shimadzu 1601, 1700, 1800).

Operation of KBR press.

GC (Shimadzu 2014) and HPLC (Shimadzu 2010) basic knowledge.

Multi-step synthesis of small molecules and their characterizations by techniques such as Chromatography, HNMR, FTIR, MS & Spectrophotometry.

Interpretation of analytical graphs like HNMR, FTIR.

Column Chromatography, TLC, Preparative TLC.

STRENGTHS:

Ambitious and driven professional with expert knowledge of the scientific, pharmaceutical and healthcare sectors coupled with an astute business acumen.

Commitment of work adoptability. Goal oriented and comfortable with team work.

Ability to take up challenges and risks, Quick learner and self motivate, Effective planning & time management, Ability to work for long hours.

Having good writing & communication skills.

COMPUTER PROFICIENCY:

Basic knowledge of computer, MS Office, Chemdraw, Internet Operating Skills, Troubleshooting.

AREA OF INTERST: Regulatory Affairs

HOBBIES:

Cricket, hockey, swimming.

Reading Books.

Music listening.

Netsurfing, I enjoy popular science and medicine and keep up to date with recent advances in these areas.

PERSONAL PROFILE:

Father’s Name : Mr. Syed Abid Ali

Date of Birth : 05-04-1984

Sex : Male

Marital status : Married

Nationality : Indian

DECLARATION:

I here declare that the above information is true to the best of my knowledge.

(Syed Mohsin Ali)

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