HEENA KHANDELWAL

** * ***** ******, ******, Massachusetts 02120 acen74@r.postjobfree.com 408-***-****

EDUCATION

Northeastern University Boston, MA

MS in Regulatory affairs for Drugs, Biologics and Medical Devices Anticipated: June 2015

Related Courses: Introduction to Drug and Medical Device Regulations, Biologics Development, New Drug Development,

Medical Device Development, Regulatory Writing.

University of Mumbai Mumbai, India

Bachelor of Pharmacy (GPA: 3.69) May 2011

EXPERIENCE

Millennium Pharmaceuticals – The Takeda Oncology Company Boston, MA

Regulatory Affairs Associate April 2014 - Present

Working in a team on Register Software to review and manage the database of Global Product Registrations.

Tracking spreadsheets and document archival regarding Takeda’s worldwide Product registrations.

Providing access to reports on registration status and number by country, product type, indication, and packaging.

Effectively manage the registration records and maintain the compliance with respect to the quality and global

regulatory bodies.

Anshul Life Sciences Pvt. Ltd. Mumbai, India

Sr. Executive – Regulatory and Technical Services December 2011 - May 2013

Promoted wide portfolio of excipients like PVP, MCC, CCS, Probiotics, Coral Calcium, Starch, Lactose, Sweeteners.

Organized and participated in exhibitions like CPHI, HPCI and Chemspec.

Ensured checking of COA, MSDS of all the excipients received from the manufacturer.

Provided regulatory guidance and dealt with quality related complaints received from customers.

Reviewed regulatory documents to ensure compliance with FDA requirements, agreements and regulations.

Regularly interacted with various internal departments in order to communicate regulatory requirements and availability

of regulatory documents.

Collected, organized and submitted documents related to regulatory filings and registration.

Assisted with general organizational activities involving regulatory files, tracking spreadsheets and document archival

process as needed.

As a management representative supervised the team of executives for implementation of ISO 9001:2008

(Quality Management system) and ISO 18001: 2007 (Occupational Health and Safety Management).

ACADEMIC PROJECTS University of Mumbai

Industrial training at Twilight Litaka Pharmaceutical Industry in the department of: May 2010

1) Quality Control; 2) Manufacturing; 3) Packaging and 4) Dispensing.

REGULATORY SKILLS

IND, NDA, ANDA, CTD, MSDS, cGMP, GLP, GCP, CAPA, VQ, FDA and IRB regulations.

Premarket approval (PMA), PMA supplements, 510K, Investigational Device Exemption (IDE), Humanitarian Device

Exemption (HDE).

Regulations governing Clinical Trials, ICH Guidelines, Informed consent process, and ethical issues involved in clinical

trials.

COMPUTER SKILLS

Windows7/8, Microsoft Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, Register Software.

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