Regulatory Affairs Associate

TOSHA DAVE

** ***** ********* ******, ******, MA 02120

LinkedIn: https://www.linkedin.com/in/toshadave

Cell Phone # 917-***-****

Email: *********@*****.***

SUMMARY

Experienced Regulatory Affairs personnel with thorough knowledge of Regulatory Strategy, and Advertising and Promotions. Demonstrated analytical and communication skills that encompass identifying critical concepts, solving complex problems, presenting complex ideas in a clear, concise and persuasive manner. Proven record of multitasking and efficient project management.

SKILLS

Regulatory Skills:

Technical Skills:

Product Strategy and Documentation

ISI toolbox

PMRs and Query Correspondence

Insight, Sharepoint

Advertising and Promotions Review

Adobe pro, Zinc

Patents and Licensing

MS Project, Word, Excel, Outlook, PowerPoint

WORK EXPERIENCE

Regulatory Affairs Associate, Sanofi Genzyme, Cambridge, MA Jan 2016- Jun 2016

Authoring and Reviewing documents for submissions for PBRERs, PSURs, SOCs, and Annual reports

Authoring and preparing documents for M1 and M5 in eCTD for submissions to IND, NDA, and sBLA

Assisting the team in strategizing clinical trials through competitor market assessment and research

Collaborating with internal Promotional Review Board and assisting in submissions of amendments to OPDP

Developing a Sharepoint for implementing a tracker on the projects and queries from global market

Liaising with supervisor to strategize and implement CAPA through collaboration with other departments

Pharmacy Technician Supervisor - Buffalo Pharmacies Inst., Buffalo, NY Mar 2013-Dec 2014

Managed a Staff of 35 Pharmacy Technicians and achieved 15% drop in Labor cost

Lead the Pharmacy Technician staff and workflow of pharmacy, successfully, during State audits

Acted as a liaison among technicians, pharmacists, technician manager and LTC manager

Assisted Company’s VP, LTC manager and Technician Supervisor identifying roots of AERs

Corresponded Company’s VP and LTC manager to strategize and implement CAPAs

Pharmacy Technician - Buffalo Pharmacies Inst., Buffalo, NY Oct 2012-Feb 2013

Initiated prioritizing tasks such as packaging of medication before filling prescriptions for next slot

Maintained sterile laboratory for sound adherence to the protocols, SOPs and GLPs

Validated Quality of prescriptions and QC all the packaging before their deliveries

Instituted all the documentation and updated databases for controlled drug substances

ACADEMIC PROJECT WORK

1.Drafted a cover letter for BLA supplement

Assessed the changes being made and strategize the type of supplement required to be submitted

Authored and prepared a cover letter for Prior Approval Supplement (PAS) for a vaccine product

Reviewed reasoning for the change and assured compliance with applicable CFR s and Guidance

Assembled all the administrative and other regulatory documentation essential for the submission

2.Regulatory Strategy and NDA Submission for Orphan Drug:

Implemented a regulatory strategy for a Rare Disease treatment

Prepared a combined Orphan Drug Designation Request for FDA and EMEA

Compiled all the administrative documentation for Accelerated Approval under 21 CFR 316

Transcribed a request for the priority review of the orphan drug NDA

Referred necessary post-market commitments and requirements

3.Preparation of an Informed Consent Form (ICF):

Drafted an ICF for a Relapse and/or Refracted Multiple Myeloma

Assessed the layman language for an effortless understanding of the trial procedures.

Assured the final ICF draft to meet all the requirements under CFRs, guidance and ICH Guidelines

Reviewed the complete ICF for accuracy and revised any intimidating language.

4.Essential Requirement checklist (for EU) for an IVDD

Drafted an Essential Requirements checklist for In Vitro Diagnostic Device

Assessed In Vitro Diagnostic Directive 98/79/EC, and listed all applicable ERs

Adjoined all the applicable standards and output data pertaining to Annex II, Class B

5.Classification and Regulatory Submission of Newly Developed Medical Device:

Strategized and authored a 510(k) submission of new device

Adjoined all applicable CFRs, ICH guidelines and Guidance Documents

Assessed conformity to ISO 13485 and put together all the administrative documents

Reviewed the label/labeling material for conformation with 21 CFR 801.

6.Prepared a Patent License Agreement for Biological Material

Drafted a patent license agreement between the Research Foundation of University and a Pharma company

Reviewed and entered the representations for parties entering agreement under the Patent Law

Reviewed the drafted agreement for appropriate statutory language

EDUCATION:

Northeastern University, Boston, MA

Master of Science, Regulatory Affairs in Drug, Biologic and Medical Device Jan 2015- Jun 2016

University at Buffalo, State University of New York, Buffalo, NY

Bachelor of Science, Pharmaceutical Sciences Aug 2008- May 2012

Achievements:

Accomplished position Dean’s list Aug 2009- Dec 2009

Commendation from Dean for Distinction in Recognition of Academic Excellence Aug 2010 – Aug 2011

CERTIFICATION

The National Institute of Health Office of Extramural Research

Completion of “Protecting Human Research Participants” course (# 1882037)

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