WORK EXPERIENCE:

Takeda Pharmaceutical International Co. May 2015-Present

Global Regulatory Affairs Labeling

Creating and updating comparison chart matrix of approved USPI and EU-SmPC labels of oncology drugs

Assist in tracking of labeling updates for marketing applications in the countries such as Canada, Switzerland, Turkey and Columbia

Assist in the labeling research to support the NDA submission activities

Performed QC review of drafts country- specific labels to ensure consistency with Company Core Data Sheet (CCDS) for oncology drugs and escalate issues to Global Labeling Lead

Scheduling and attending cross-functional meetings with functional areas such as GRA Strategy, Pharmacovigilance, Clinical Pharmacology, Commercial and Legal

Documenting and distributing meeting minutes to the team members and tracking action items related to labeling.

Prepare the assessment on the current FDA OPDP enforcement trends related to advertising and promotional materials for oncology products

Organizing and maintaining labeling documentation on project specific SharePoint site for easy access by the project teams

Liberal Pharmaceuticals – Mumbai, India

Jr. Regulatory Affairs Associate Jan.2011- Jun.2012

Assisted in drafting marketing dossiers for antibiotics and anticancer drugs as per country specific CTD/ACTD format with appropriate regulations

Determined appropriate submission requirements and strategies to meet precise timelines

Prepared documents used for product dossier supplements, amendments and variations

Reviewed and evaluated quality documents and labeling material such as tray labels, cartons, package inserts, etc.

Khandelwal Labs Pvt. Ltd – Mumbai, India

Quality Assurance Intern Jun.2011-Jul.2011

Documented, maintained and archived batch manufacturing records, calibrated lab equipment and drafted product stability protocols as per GMP

Reviewed and updated various departmental SOP’s such as BMR, protocol deviation and implementation of CAPA

EDUCATION:

Northeastern University, Boston, MA (Expected) Mar.2016

Master of Science in Regulatory Affairs, Biologics and Medical Devices GPA:3.80/4.00

University of Mumbai, Mumbai, India Aug.2008-Jun.2012

Bachelor of Pharmacy

SKILLS AND CORE COMPETENCIES:

Regulatory Submissions: IND, NDA, ANDA, BLA, Case Report Form, Structure Product Labeling, Post Marketing Periodic and Annual Reports, well versed with eCTD backbone

Regulatory Compliance: CPP, cGMP, GLP, GCP, USPI, SmPC, Pharmacovigilance, Labeling Requirements, Advertising and Promotion and Clinical Trials

Computer Expertise: Proficient with publishing tools like, eCTDXpress,, Galaxy and Electronic document management systems (EDMS), Microsoft Office, Knowledge NET, SQL, Adobe Acrobat, Documentum, MS Share Point, MS Visio, Adobe Illustrator

Other: Team player, Strategy Planning and attention to detail

ACADEMIC PROJECTS:

Mock BLA/BLA Supplement filings and Labeling submissions:

Compiled a BLA using product information, preclinical and clinical data, labeling contents; and a supplement for updating previous label version including boxed warnings and extended use

Drafted a cover letter for BLA supplement and prepared the labeling changes for extending intended use of HPV vaccine

Mock IND/ NDA filing and submissions:

Drafted a cover letter along with FDA form 1571 requesting Pre-IND meeting to discuss clinical hold for Northera® (droxidopa) in the treatment of Neurogenic Orthostatic Hypotension to the FDA

Drafted a request letter for Orphan drug designation for Northera® (droxidopa) to the FDA

Drafted a NDA 505(b)(1) and 505(b) (2) submission for a drug product with a 356h form

CERTIFICATIONS:

Participated in “Protecting Human Research Participants” by National Institute of Health Office of Extramural Research, License 1521852.

The past, present and future of FDA human drug regulation certificate by FDA

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