Regulatory Affairs Professional

SANDEEP KR. SHRIVASTAVA

** ***** ******, **. **********, ON L2M5R4 Canada • Cell: 647-***-**** • Email: *********@*****.***

SUMMARY

Dedicated and focused who excels at prioritizing, completing tasks simultaneously and following through to

achieve project goals.

STRENGTHS

• More than 8 years of extensive experience in Global Regulatory Affairs Department and Analytical

Development Lab (Generics - Oncology).

• Extensive knowledge and hands-on experience of regulatory submissions to various regulatory bodies viz.

Europe, US-FDA, Japan, and Emerging Markets.

• Good understanding of Canadian regulatory submissions viz. Abbreviated New Drug Submission (ANDS),

post approval activities/changes - Supplement to an Abbreviated New Drug Submission (SANDS),

Notifiable Change (NC) etc.

• Expertise in reviewing submission related documents and strong dossier compilation skills.

• Effective communication and networking skills.

• Ability to establish and maintain good working relationships at all levels.

• Strategic thinking, good planning skills and time management.

• Ability to recognize essential details and maintain an overview.

• Good analytical and problem solving skills.

• Coordinate and work effectively in a team oriented environment.

•Commitment towards work, taking full ownership of the task and delivering satisfactory & timely.

•Adaptable, quick learner, self-directed, dedicated, able to multi-task, confident and result oriented.

ACHIEVEMENTS

At Fresenius Kabi Oncology Ltd.

•Initiated first regulatory filing for Japan.

•Nominal queries received from the European regulatory authorities, resulted in a nearly procedural close. The

assessment timetable for the Decentralized Procedure (DCP) in Europe is 210 days while the procedure

closed at Day 160, leading to approval of the drug product.

•Successful submission of Para IV filing.

•Promoted for consecutive years.

At University

•Ranked first in presentation given on topic “Is it worthwhile to develop me too Viagra or one should

concentrate more on PMS (Post Menstrual Syndrome)” during the Post graduate study program.

IT/E-CTDSKILLS

•Extensive knowledge of MS Word, Power Point, MS Outlook, Lotus notes, Internet search tools and Adobe

Acrobat Standard.

•Hands on experience on eCTD tools like PharmaReady (from Take Solutions) and KIPDIPS (in-house dossier

compilation tool used within Fresenius Kabi).

PROFESSIONAL EXPERIENCE

Regulatory Affairs Associate

Biolyse Pharma Corp., Canada (November 2014 - Till date)

• Responsible for regulatory submissions in Europe, Canada and Emerging Markets.

• Reviewing submission related documents for e.g. Batch records, Process validation Reports, Stability

protocols and reports, Specifications and Testing procedures, Analytical Validation Reports, Pharmaceutical

development reports, etc.

Assistant Manager - Regulatory Affairs

Fresenius Kabi Oncology Ltd., India (January 2014 - August 2014)

• Previous positions held in Regulatory Affairs at Fresenius Kabi Oncology Ltd., India are:

- Senior Research Scientist-II (January 2013 to December 2013).

SANDEEP KR. SHRIVASTAVA

38 Cosby Avenue, St. Catharines, ON L2M 5R4 Canada • Cell: 647-***-**** • Email: *********@*****.***

- Senior Research Scientist-I (January 2011 to December 2012).

- Research Scientist (August 2009 to December 2010).

SANDEEP KR. SHRIVASTAVA

38 Cosby Avenue, St. Catharines, ON L2M 5R4 Canada • Cell: 647-***-**** • Email: *********@*****.***

Job Profile:

• Submission of Marketing Authorization Applications/ post approval changes in Europe, US, Japan, and

Emerging Markets.

• Collate data from relevant departments and examine it in relation to the regulatory requirements of the

countries/ regions in the project scope.

• Assist functional lead interactions with regulatory authorities by gathering and communicating relevant

information from and to project team.

• Lead the team in preparing high quality regulatory dossiers for the projects assigned and for the regions

defined in the project scope. Oversee regulatory submission activities within defined time schedules and in

accordance with established standards and protocols.

• Review of technology transfer documents and change controls.

• Ensure all submissions are satisfactory submitted and approved within set timelines.

• Update with legislation changes/ regulatory requirements and anticipate their impact on the current and the

proposed approvals.

• Maintained the status and archival track record of various submissions viz. new filings, post approval

changes.

• Provided support to other teams within the regulatory department as and when required.

Research Scientist - Analytical Development

Dabur Research Foundation, India (January 2007 - July 2009)

• Analysing samples from various sources to provide information on compounds or quantities of compounds

present.

• Interpreting data and reporting/ presenting results.

• Using analytical techniques and instrumentation, such as high performance liquid chromatography (HPLC),

spectroscopy (infrared and ultraviolet), Karl Fischer Titrator etc.

• Developing techniques for the analysis of drug products.

• Validating methods and equipments.

• Setting specifications for the drug products.

• Establishing method equivalency for various pharmacopoieal methods.

• Performed test method transfers.

• Working collaboratively in cross-functional teams.

• Documenting internal audit and other quality assurance activities.

• Prepared reports to communicate outcomes of quality activities.

Project associate - Analytical Development

Ayurvet Research Foundation, India (January 2006 - January 2007)

• Accountable for literature search and data collection for ongoing research projects.

• Developing and maintaining detailed project schedule including administrative tasks and all sites involved

in the project.

• Participating in R&D Team Meetings.

• Coordinate meetings, including travel arrangements and expense reports.

• Prepare and/or edit meeting minutes, presentations and tables.

• File all project documents (hard and soft copies).

EDUCATION and TRAINING/ WORKSHOPS

• Master of Pharmaceutical Sciences, University of Greenwich, United Kingdom, 2005.

SANDEEP KR. SHRIVASTAVA

38 Cosby Avenue, St. Catharines, ON L2M 5R4 Canada • Cell: 647-***-**** • Email: *********@*****.***

• Bachelor in Pharmacy, Dr. B.R Ambedkar University, India, 2003.

• Diploma in Pharmacy, Haryana Technical Board, India, 1998.

• Post Graduate Diploma in Business Management, Institute of Management Technology India, 2012.

• Merck-Millipore: Filtration School Workshop held at Bangalore, India [for 1 week in Nov. 2011] .

• Quality by Design workshop held in Ahmedabad, India [for three days in Sept. 2012] .

REFERENCES

Available upon request.

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