1. DEEPAK MANOHAR SAINDANE
E -Mail ID: deepu_saindane@yahoo.com Mobile: +91-
9920988509
PROFILE SUMMARY:
A results-oriented pharmaceutical professional with 10+ years of hands-on work experience in
Pharmaceutical Regulatory Affairs field with knowledge of regulatory submission process
required in order to register products across regulated and semi-regulated markets.
EXPERIENCE CHRONOLOGY
Since May’ 09-Till Date
APOTEX RESEARCH PRIVATE LIMITED, Mumbai
TEAM LEADER - Regulatory Affairs Department
Job Responsibilities:
• To manage, lead and oversee the overall regulatory dossier submission for Solid Oral
Dosage form Dossiers, Deficiencies and Product Lifecycle Management for regulated
market US, Canada, EU & Australia.
• Development of regulatory strategies, identify and prioritize assignments, key issues in
addition to implement regulatory plans in the best and most efficient way possible in
accordance to meet the time lines for registration of new products, variations and product
lifecycle management.
• Regulatory dossiers submissions for Co-Development project with other pharmacucatical
companies.
• Understand and prepare CMC response pertaining to regulatory submissions for all product
specific queries arising from various customers and regulatory authorities.
• Maintain single point contact to coordinate activities within company and with company
counterparts, as needed.
• Review and approve Change Controls related to NPD projects [New product Development].
• Anticipated queries and Rate limiting factors during review and compilation of submissions
and deficiency and always tried come up with creative solutions to it.
• Constantly enhance the quality of submissions by implementing new ideas, strategies in
presentation of the dossiers, keeping in mind learning’s from the past deficiencies.
• Review of quality documents as per regulatory requirements.
• In depth knowledge and hands on experience of eCTD & Document Management Software
like RIMS, Docubridge, Content 7, labelbridge, Trackwise and PIMS.
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2. • Coordinate and consult with other department for accurate and timely assembly of
regulatory document for submissions.
March’ 07 to April 09:
STRIDES ARCOLAB LIMITED, Bangalore
Executive, Regulatory Affairs Department
Job Responsibilities:
• Compilation of Injectable Dossiers and respond to deficiencies for US market.
• Writing CMC part and Filing Injection ANDA in eCTD format.
• Collect and review quality documents and filing for parenteral and oral dosage form.
• Coordinate and consult with other department on the content review, and assembly of
regulatory document for US submissions.
• Ensure adherence to the delivery and quality requirements.
• Compiled dossiers for regulatory authorities of different countries (African countries and
South East Asia).
• Prepare responses to the legal queries made by the Regulatory authorities.
• Maintain up-to-date knowledge of the data, information, and formats required for inclusion
in these applications.
September 04 to June 05:
LYKA LABS LIMITED at Tarapur, Dist: Thane
Trainee Production officer
Job Responsibilities:
• Work experience of Granulation, Compression, Coating (pan-cota, neo-cota), packaging,
capsule filling, and Dry syrup filling.
• Responsible for production of tablets, dry syrup, capsule filling.
• Co-ordinations with Q.C., Q.A., Store, Packing and Administration for the production of
safe, pure and effective product.
• Worked in Pkg. Dept. & Manufacturing Dept. familiar with day to day working.
• Reporting to Dept. Head, Unit Head.
• Production planning, labour Utilization, day to day working & documentation.
Jun.03 to Jul. 03:
Industrial Training in EMIL PHARMACEUTICAL in formulations (tablets, capsules,
liquid orals & quality control dept) at Tarapur, Dist: Thane
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3. ACADEMIC CREDENTIALS
QUALIFIED
EXAMS
SCHOOL/COLLEGE
UNIVERSITY/
BOARD
YEAR
MARKS
%
M. Pharmacy
K.L.E.S’s College of
Pharmacy, Belgaum
R.G.U.H.S.
Bangalore
2007 72.14
B. Pharmacy
P.D.V.V.P.F’s College of
Pharmacy, A.Nagar
Pune University 2004 60.76
D. Pharmacy
M.A.H. College of
Pharmacy, Boradi
M.S.B.T.E. 2001 62.10
COMPUTER PROFICIENCY
 Office Package: Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
Express.
 Operating Systems: Windows XP, Windows Vista
PERSONAL DETAILS
Permanent Address : Flat No-401, 4th floor, Building no: B-6, Swastik Park ‘B’ Co. Operative
Housing society, Next to Bramhand Hsg. Complex, Azad Nagar, Off.
Ghodbunder Road. Thane (West) 400607, Maharashtra.
Date of Birth : 15 September 1981
Marital Status : Married
Language Known : English, Hindi, Marathi, Gujarati and Kannada
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