Mitul Tilala

*** ******* ****** **********, ** **095 347-***-**** acoyb5@r.postjobfree.com

REGULATORY AFFAIRS

Expertise in Pharmaceutical / Biotech Industry

Results-driven Pharmaceutical / Biotech Regulatory affairs candidate offering 5 years of progressive

experience and expertise in regulatory affairs, CMC for pharmaceuticals/biotechnology products. Proven success in

regulatory affairs and creating innovative marketing strategies to develop business, expand customer base, and

drive revenues.

Drug Regulatory Affairs ANDA Submission PADER

Chemistry, Manufacturing and Control Project Management Regulatory Compliance

Research Data Collection & Analysis Product Marketing & Launch Annual Report

Market Positioning & Analysis FDA Correspondence Market Research & Strategies

Negotiation Skills Multi-Campaign Management Regulatory Compliance

Vendor Relations & Selection Problem Solving / Resolution Outsourcing

Consumer Trend Analysis Presentations / Public Speaking New Business Development

PROFESSIONAL EXPERIENCE

2012 – Present

EMCURE PHARMACEUTICALS, INC., East Brunswick, NJ

Regulatory Affairs Associate

Prepared and submitted Annual Reports to maintain Product Life Cycle.

Prepared and submitted Quarterly and Annual Periodic Adverse Drugs Experience Report.

Compiled and Published the dossier to FDA through Electronic Submissions Gateway (ESG).

Managed regulatory related activities with vendors.

Assisted in preparation and submission of ANDA and Amendments.

Coordinated with various departments and ensured the timelines are met

Maintained records of FDA correspondence.

PHARMALINK CONSULTING, Short Hills, NJ 2012

Contract Independent consultant for Pfizer - CTD Analyst

Split-redacted and complied required documents mapped it to new format.

Tracked monthly and ongoing project errors for IQC.

IQC’ed the formatting of collation analyst builds.

Knowledge of Regulatory submissions like IND, NDA, ANDA, CTA, 510(k), PMA, and annual report.

Familiar with FDA regulation, eCTD, ICH guidelines, variation, renewal, knowledge of IND/NDA.

2011 – 2012

PHARBEST PHARMACEUTICALS, INC., Farmingdale, NY

Marketing Executive

Conducted primary and secondary market research to support the development of new business for company’s

broad range of OTC products. Delivered presentations to customers on products. Collaborated with all other

departments within company to implement marketing strategies.

2009 – 2010

LONG ISLAND UNIVERSITY, Brooklyn, NY

Graduate Teaching Assistant, Social and Administrative Sciences (2010)

Graded assignments and conducted recitations for Pharm.D. students enrolled in various courses, including Public

Health, Behavior & Ethics, and Communication.

Research Assistant, Social and Administrative Sciences (2009)

Researched whether phone calls or text messaging can improve well -being in patients with Type 2 diabetes.

Collected primary data for project from the 2009 Diabetes-Expo Conference.

Continued…

Mitul Tilala Résumé / Page 2

PROFESSIONAL EXPERIENCE continued …

ALLIED CHEMICALS, Ankleshwar, Gujarat, India 2008

Associate Manager

Managed production batches, while maintaining stringent GMP regulations. Established and maintained customer

relationships.

2007 – 2008

LINCOLN PHARMACEUTICALS, LTD., Ahmedabad, Gujarat, India

Summer Intern

Gained in-house experience in the manufacture of pharmaceuticals and regulatory affairs.

EDUCATION

Goldey-Beacom College, Wilmington, DE May 2014

M.B.A., International Business

Long Island University, Brooklyn, NY 2010

M.S., Pharmacy Administration (Marketing), 3.7 G.P.A.

Rajiv Gandhi University of Health Sciences, Jayanagar, Bangalore, India 2007

B.S., Pharmacy, 3.8 G.P.A.

GRADUATE RESEARCH EXPERIENCE

Pharmacist Response Towards Patient Aggression

Conducted literature review, created study design, and collected data.

Behavioral Pharmacy Research by Social and Administrative Science Faculty

Collected secondary research data from various sources.

GRADUATE CURRICULAR PROJECTS

Market Research: Studied the customer perception towards the generic drugs in comparison with brand drugs.

Pharmacoeconomics: Conducted cost benefit analysis of Pennsaid for osteoarthritis of the knee using secondary

data.

Drug Regulatory Affairs: Presented a comprehensive literature review on history, regulations, and marketing

aspects of orphan drugs.

Research Methodology: Tested association between knowledge about generic drugs and likelihood of request for

generic drugs.

Advertising and Promotion: Conducted market research on advertising strategies for iPhone 3G.

Marketing Management: Developed market planning for Longevity Healthcare Center.

AWARDS

Graduate Teaching Assistant Award, January 2010 and September 2010

Research Assistant Award, 2009

COMPUTER SKILLS

Microsoft Word, Excel, PowerPoint, Access, SPSS, SAS, TREEAGE

PERSONAL

Legally authorized to work in the U.S.

Contact this candidate