Contact

Sri Divya Harkara MS-RA,

www.linkedin.com/in/sharkara
(LinkedIn) RAC, PMP
Regulatory Submissions/Operations/eCTD Publishing SME | MS in
Top Skills Regulatory Affairs | RAC US | PMP
Somerset, New Jersey, United States
Regulatory Affairs
eCTD
510 K Summary
• High degree of knowledge regarding the dossier assembly/
Certifications production process and the structural organization, standards and
RAC (US) requirements of regulatory dossiers.
Registered Pharmacist • Thorough knowledge of U.S. FDA Regulations and ICH Guidance
Confronting Bias: Thriving Across as they apply to the creation of investigational drug and marketing
Our Differences
applications.
Communicating about Culturally
Sensitive Issues • Prepared, reviewed and submitted 7 IND applications, 2 Major
Project Management Professional NDAs, 1 BLA, 7 sNDA/sBLA, 3 ANDA submissions, along with
(PMP)® extensive experience with all lifecycle submissions.
• Well versed in ICH and eCTD requirements. Well versed in all
dossier formats, standards, navigation, and life cycle management.
• Capable of working in a fast paced environment with moving
targets. Demonstrated highly developed interpersonal,
communication, negotiation, and facilitation skills.
• Possess expertise in GlobalSubmit Review and Validate, ISI eCTD
Express, Insight for Publishing and Viewing (User+admin) Datafarm
eCTD Builder and eCTD Viewer, Extedo eCTD Manager, EURS,
Lorenz validator and other eCTD validation tools
• Extensive experience with Electronic Document Management
Systems like Veeva Vault (Cloud) Domasys, Documentum, IRiS and
LiveLink.
• Skillful in working with Adobe Acrobat DC and Pro (thru v10) and
various plug-ins like ISIToolBox Pharma Edition and Liquent a-Pulse/
Smartdesk.
• > 12 years’ experience working with MS Word, Excel, Visio and
Project. Possess basic knowledge of XML and SPL
• Stays abreast of industry developments and relevant new
regulatory requirements in US, EU, Canada and other Health
authorities.

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Experience
Regeneron Pharmaceuticals, Inc.
Associate Manager, Regulatory Operations
January 2020 - Present (3 years 10 months)
Basking Ridge, New Jersey

• Provided guidance to multidisciplinary teams on developing submission

structure strategies in accordance with applicable Regulatory Agency
regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
• Provided guidance on good documentation and submission practices
• Assisted with developing and maintaining Regulatory document processing
and Regulatory submission publishing standards and procedures in
accordance with all applicable Regulatory regulations, guidance, and
specifications.
• Electronically format, publish electronic documents and builds Regulatory
submission deliverables and ensures quality, accuracy, and submission-
readiness per Regulatory agency guidance and specifications, and internal
procedures.
• Identified and communicated regulatory system enhancement needs or
technical issues
• Assisted with regulatory inspection activities
• Collaborated with vendors who support Regulatory operations related tasks.

Sanofi
6 years 11 months

Dossier Specialist
September 2016 - January 2020 (3 years 5 months)
Bridgewater, NJ

● Responsible for managing the planning and delivery of regulatory

submissions required to support the development and registration of new
products.
● Contributed to the development of the compilation strategy and scheduling
of submissions to provide a fully navigable, reviewable and compliant
submission, ensuring a high quality dossier to the agency.
● Tracked the workload, capability to assign tasks to a specific publisher,
ensuring the timely finalization of all submissions.
● Participated in discussions with submission task force teams involving
electronic guidance issues to ensure an appropriate understanding of
electronic submission requirements. Supported the regulatory department on
various due diligence activities

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● Lead the creation and maintenance of submission plan based on thorough
understanding of publishing tools and processes.
● Leadership in establishing trusting partnership with external co-developer
pharmaceutical companies for implementation of eSubmission strategies
between two companies.
● Demonstrated expertise on all dossier formats, standards, navigation, and
life cycle management globally to key stakeholders to ensure on time delivery
of high quality dossiers in compliance with Health Authority requirements.
● Worked within project teams in the control of submission component receipt
and workflow completion to ensure that issues are identified at an early date
and actively contribute to issue resolution before filing dates are impacted
● Participated in internal working groups related to electronic regulatory
submissions with the ability to assess the application of agency requirements
from an internal perspective.
● On-boarded, trained and mentored new-hires (contractors) within the team
● Lead publisher for the largest Sanofi submission till date (200 GB)
● Lead the creation and revision of relevant process sheets, working practices
and QWINs
● Demonstrated PM expertise supporting operational planning and
coordination of 100+ ARs.

Regulatory Affairs Associate II

March 2013 - September 2016 (3 years 7 months)
Framingham, MA

● Developed thorough understanding of submission production from a

technical perspective from initial preparation to dispatch of compliant modules
1 through 5
● Worked as a lead publisher for several IND applications along with a major
NDA
● Managed Safety Reporting submissions for all Genzyme INDs and
maintained the MSRT
● Communicated and coordinated the receipt of finalized documents from
contributing authoring functions. Ensured compliance with Regulatory Agency
rules and guidelines pertaining to regulatory submissions (electronic and
paper) across multiple regions
● Collaborated with the internal Regulatory Affairs and Regulatory Strategy
teams to plan regulatory submissions ahead; made sure the documents are
received in time; prepared and submitted submissions that are compliant and
well within industry standards

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● Experienced in adapting to and supporting new publishing systems/tools,
standards, and process efficiencies; like working in Citrix and Veeva (Cloud)
● Prepared and submitted several eCopies (30 Day Notices, Supplements,
Amendments, Annual Reports, and IDE Progress reports) related to
Biosurgery products (Medical device products) at Genzyme to CDRH at FDA
● Prepared and submitted 483 inspection responses, Field Alert Reports
(FARs), and Biological Product Deviation Reports (BPDRs)
● Prepared Quarterly Reports, Response to Observations, Commitment Status
Reports to agencies like FDA, TGA, Health Canada, PMDA, ANVISA and
CFDA
● Created, deployed and maintained an internal Body of Knowledge
SharePoint site. Enabled users to populate content like submission calendars,
presentations and best practices

Cipla USA (Formerly InvaGen Pharmaceuticals Inc.)

Regulatory Affairs Associate
April 2012 - March 2013 (1 year)
Hauppauge, NY

● Prepared and submitted regulatory submissions (ANDAs) for new drugs and
formulations intended for commercial distribution
● Submitted supplements and annual reports to the agency through-out the life
cycle of the approved ANDAs.
● Prepared and submitted labeling (CBE-0 and CBE-30) of the ANDAs
● Developed thorough and current understanding of agency and other
appropriate regulations pertaining to regulatory & technical requirements for
electronic documents and all types of submissions
● Communicated and coordinated with various departmental teams in
implementing controls and measurements to ensure quality and regulatory
compliance
● Participated in patent evaluation activities, writing and development of non-
infringing formulations, methods etc
● Performed and maintained regulatory affairs and regulatory compliance
functions
● Reviewed and assessed change control proposals with respect to product
development and regulatory requirements
● Developed an ability to focus on timely delivery while working under pressure
in a fast-paced environment dealing with multiple tasks.
● Represented InvaGen at lab inspections, and meetings with regulatory
agencies.

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● Performed REMS, SPA (Special Protocol Assessment), recall management,
adverse event reporting, complaint handling, and internal audits.
● Observed and documented supplier related deviations and associated
CAPAs
● Conducted communication with the agency and document the
communication
● Prepared and submitted adverse event reports to the agency.
● Participated in internal regulatory inspections in the laboratory for
compliance with current regulations, industry practices and internal policies
● Prepared reports, SOPs and recommendations based upon research
outcomes

Genzyme
Regulatory Operations Publisher
October 2011 - March 2012 (6 months)
Cambridge, MA

● Coordinated and prepared submission packages ensuring compliance with

defined standards and practices.
● Coordinated, compiled, submitted and archived more than 200 internal and
more than 20 FDA Ad-Prom submissions
● Prioritized and managed daily tasks associated with regulatory submissions
publishing projects including word processing, technical preparation, QC
and assembly. Adapted to new work requests with minimal instruction and
guidance needed
● Performed the duties of Regulatory Information coordinator preparing,
uploading and archiving large volumes of regulatory documentation
● Gained highly developed document management skills. Archived 100s of
submissions, tracked changes and ensured proper retrieval of documents in
the eDMS.

Education
Northeastern University
Masters, Regulatory Affairs for Drugs, Biologics, and Medical
Devices · (2009 - 2011)

Osmania University
Bachelors, Pharmacy · (2005 - 2009)

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