Preparing the dossier as per the CTD/ACTD and non CTD (Country Specific) Format for semi-regulatory market for Pharmaceuticals as well as Nutraceuticals formulations. - Compilation, Review, Preparation and Submission of Annual Report for approved products in CTD format. - Review and check DMF’s and BE study Report. - Review and check BMR, BPR, Product Specifications, excipient specification, MOA, COA, Manufacturing Formula, PV, TMV, AMV, PM, FP & stability data. - Handling technical / administrative queries pertaining to regulatory submissions and responding them on time - Handling clients / customer queries related to regulatory aspects for products. - Impact analysis on submitted dossiers during assessment phase due to change in regulations or requirements and Coordination with other internal and external parties in dossier /query compilation stage.

1. CURRICULUM VITAE
Taiyyab Kadar Shaikh
Mob: +9561307250/+7387620248
E-mail: taiyyab1234@gmail.com
Career Objectives
Ideally focus myself for the position requiring innovation that will utilize my knowledge and
professional skills and always strive for excellence. I am young and enthusiastic and wanted to
make carrier in Regulatory Affair Department.
Work Experience - 2 Year and 7 Months
1. Currently Working at Merck Life Science Pvt Ltd Mumbai
As Associate- Drug Regulatory Affairs from December 2015 till present
2. Previous Work Experience - Medibios Laboratories Pvt. Ltd. Mumbai (1Year 4 Months)
As Executive- Drug Regulatory Affairs from Aug. 2014 to Dec.2015
3. Previous Work Experience - VHB Life sciences Pvt. Ltd. Mumbai (8 Months)
As Institutional Manager-3 in Pune (Pharma Sales) from Dec.2010 to July 2011
Job Work Profile -
Dossier Filing (Solid Orals):
- Preparing the dossier as per the CTD/ACTD and non CTD (Country Specific) Format for
semi-regulatory market for Pharmaceuticals as well as Nutraceuticals formulations.
- Compilation, Review, Preparation and Submission of Annual Report for approved products in
CTD format.
- Review and check DMF’s and BE study Report.
- Review and check BMR, BPR, Product Specifications, excipient specification, MOA, COA,
Manufacturing Formula, PV, TMV, AMV, PM, FP & stability data.
- Handling technical / administrative queries pertaining to regulatory submissions and
responding them on time
- Handling clients / customer queries related to regulatory aspects for products.
- Impact analysis on submitted dossiers during assessment phase due to change in regulations or
requirements and Coordination with other internal and external parties in dossier /query
compilation stage.
- Prepared and reviewed many SmPC's and PIL for the submissions in the Domestic and ROW
country
- Prepared and Reviewed artworks (SPC, PIL, Carton, Foil and Label) for ASEAN, CIS, and
LATAM countries.
- Liaise with manufacturing sites and product teams when required.
- To be involved with all registration related tasks- Post Approval Authorization Variations.
- Preparing and submitting regulatory documents in an efficient and timely manner.
- Careful planning to achieve accurate and timely results.
- Update licensing and collect information on registration instructions and regulations.
- Making draft of COPPs, FSC, Test License, NOC and Product Permission.
Work for Countries- (ASIAN, AFRICAN, LATUM) : Vietnam, Thailand, Philippines,
Myanmar, Chile, Nigeria, Ghana, Uganda, South Africa, Srilanka, Costa Rica, Dominican
Republic, Panama, Uruguay.

2. SCIENTIFIC AND TECHNICAL KNOWLEDGE AT A GLANCE
- Scientific literature search as per requirements of project, collating the search results.
- BCS, Bioavailability, Bioequivalence, SUPAC guidelines, and ASEAN variation guidelines,
European variation guidelines
- ICH Quality, Multi-disciplinary, FDA- Dissolution guidelines.
- Well versed with IPAQ testing of product, validation, deviation, change control, CAPA
handling and Audit.
- Orange Book, Reference Listed Drugs (RLD), Inactive Ingredient Guide (IIG), Various
regulatory bodies across the Globe such as USFDA, EMA, MHRA, PMDA, TGA, MCC.
Academics
Project Work (Pharmaceutics)
Formulation and Development of Floating Mucoadhesive Microspheres of Ramipril by
Emulsification Solvent evaporation Method.
Areas of Interest
 Regulatory Affairs
Publication
- Two Review Articles Published in International journal.
- Two Research Articles published in International journal.
Computer Skills
- Basics software knowledge like SAP system
- MS word, MS Excel, MS Power point, Chem-sketch software, Coral draw.
- PDF editor, Adobe reader
Personal Information
Date of Birth : 16th
May 1988.
My Strength : Hardworking, consistency in work, Enthusiastic and high achiever. Self-
motivated, ready to learn & grasp.
Lingual Skills : English, Hindi, Marathi.
Gender : Male.
Marital Status : Married
Address : At Post - Tawashi, Tal - Pandharpur, Dist- Solapur 413304.
Declaration
I hereby declare that the above-mentioned information is correct up to the best of my knowledge
and I bear the responsibility for the correctness of the above-mentioned particulars.
Dated: / / Taiyyab K. Shaikh.
Exam Year University / Board Percentages Class
M. Pharm (Pharmaceutics) 2011-13 Pune university 64.86 First class
GPAT 2011 University of Baroda Qualified Qualified
B. Pharm 2010 Solapur university 72.50% First class
H.S.C. 2006 Maharashtra Board 63.83% First class
S.S.C. 2003 Maharashtra Board 70.80% First class