Regulatory Affairs

Work Experience

Syner-G Pharma CMC Consulting LLC, Newton MA

Feb 2013- Present

Regulatory Affairs Specialist at Client site- Cubist Pharmaceuticals, Inc.

- Providing regulatory support to ensure compliance with United States Food and Drug Administration (US-FDA) regulatory requirements

* Responsible for planning and submission of annual reports (IND and NDA) and periodic reports like REMS Assessment, PADER, PSUR and DSUR for development and marketed products

* Represent regulatory affairs in study teams responsible for the fulfillment of post-marketing commitments as well as US-FDA Written Request (non-clinical as well clinical study report submissions)

* Preparation and submission of meeting requests and briefing documents for meetings with US-FDA (Type A, B and C) for various post-marketing activities

* Assist in preparation for Advisory Committee meeting- work with cross functional teams for preparation of briefing document and presentation slides, complying with administrative requests from the FDA (redaction waivers, presentation outline, list of investigators etc.), management of timelines and preparation of the meeting

* Submission of supplements and amendments to NDA (sNDA submission, response to Agency requests, labeling negotiations, changes to REMS document and REMS materials )

- Provided regulatory support to global clinical trials group

* Worked closely with the Contract Research Organization (CRO) to manage and track multiple global clinical trial applications for four clinical trial programs in US, Latin America, Middle East, Asia, Australia

* Managed responses to questions from global health authorities- work with internal team and CROs to identify and assign responsibilities, assist in drafting, compiling submission of responses as per health authority requirements

* Reviewed site regulatory packages and sign-off on drug shipment release to clinical trial site

* Developed regulatory project plans (RPP) and other agreements like quality management plan (QMP) with the contract research organization for the management of global clinical trials

* Trained interns/ new hires on processes related to submission of clinical trial applications by creating training plans, work plans and assignments

Packard Consulting (Medical Device)- Chester, VT

Nov 2012- Jan 2013

Regulatory Affairs Consultant (Part-time)

- Part-time consultant working with companies to support regulatory submissions for medical devices

- Prepared pre-market notification 510(k) to obtain market clearance from FDA for a Class II medical device for a client

- Researched predicate device, locate guidance documents, maintain 510(k) planner and table of contents and prepare sections of 510(k) submission

- Created templates for various sections of pre-market notification for current and future clients

Cubist Pharmaceuticals, Inc. Lexington, MA

Oct 2012- Jan 2013 Regulatory Affairs Associate II (Contractor)

- Prepared and managed multiple IND and NDA Annual Report submissions for developed and development product with overlapping reporting periods

- Compiled meeting requests and briefing documents for Type C meeting with US-FDA

- Supported activities related to post-marketing pediatric commitments for developed products- submitting waiver requests, proposed pediatric study request (PPSR) and protocol for pediatric studies.

- Supported US and ex-US pediatric clinical trial activities:

* Increased team efficiency by introducing planners, trackers, best practices and responsibility matrix for sponsor-related activities during clinical trials.

* Work with CRO and other internal teams (CMC, Clinical, Legal) to prepare submission of responses to questions from international regulatory authorities

* Provide sponsor related administrative documents like Letter of Authorization (LOAs), Sponsor Declaration as per the notarization and legalization needs

Cubist Pharmaceuticals, Inc. - Lexington, MA

Jan 2012- Sept 2012

Regulatory Liaison Co-op

- Archived regulatory submissions using FileMaker Pro and audited legacy regulatory submissions to ensure smooth transitioning into new archive software

- Optimized and executed processes for provision of sponsor related documents requested by vendors - specifically LOAs, Declarations, Certificate of Pharmaceutical Product (CPP) and GMP certificates as per country specific legalization requirements

- Created templates and planners for regulatory submissions like meeting requests, briefing documents and annual reports using ISI Toolbox

- Assisted in QC and review of submissions as per submission standards- bookmarks, hyperlinks, page settings, document properties

* US submissions- Annual Reports, Investigator Updates, Protocol Amendments, Meeting Requests and Briefing Documents using ISI Toolbox

* EU submissions- Pediatric Investigational Plan (PIP), Active Substance Master File (ASMF) and IMPD (Investigational Medicinal Product Dossier)

Amgen Inc. -Thousand Oaks, CA

July 2011- Oct 2011

Grad Intern, Global Regulatory Affairs and Safety

- Created a comprehensive regulatory intelligence sharepoint site for regulatory requirements for clinical trials and marketing authorization in emerging market countries by conducting intelligence research on country level requirements for filing clinical trial applications (CTA), marketing applications, variations and renewals for emerging markets utilizing Ministry of Health websites and intelligence databases like IDRAC and Tarius

- Reviewed company’s CTA packages in emerging markets against country specific requirement to verify and document completeness of the application; and report deficiencies, if any, to the CRO

Ranbaxy Laboratories Ltd. - Dewas, India

July 2009- Aug 2009

Intern, QA Documentation

- Assisted in maintenance of regulatory inspection records (general inspection information, observations and responses)

- Compiled SOP- training database in Microsoft Excel for Quality Assurance purposes prior to an internal audit

Education

Northeastern University Boston, MA

Sep 2010- Apr 2012

Master of Science in Regulatory Affairs,

- Award: Dean’s Scholarship to International Students for the study of International Regulatory Affairs

Rajiv Gandhi Technical University Bhopal, India

Oct 2006-Jun 2010

Bachelor of Pharmacy

Professional Certification

-RAC Certification- Regulatory Affairs Professional Society,December 2013

Presentations

P. Nambiar, D. Doshi, H. Gutka. CMC-Information Relational Map of Module 3. AAPS Conference 2013

Computer Skills

MS Office- Word, Excel, PowerPoint, Project, Visio, SharePoint

Regulatory Intelligence- Cortellis, Pharmapendium, Tarius

Publishing and Archiving- ISI Toolbox, Adobe Acrobat Professional, FileMaker Pro

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