Sadhana D. Kalinani, Esq.

** **** ****

Randolph, New Jersey 07869

acb5z5@r.postjobfree.com

(C) 973-***-****

Objective: To obtain a challenging position as a Corporate Counsel in a competitive

pharmaceutical/medical device company that will utilize my diverse legal, regulatory, and clinical

research experience.

Experience:

LifeCell Corporation June 2011 to January 2014

Director of Regulatory Affairs and Compliance

• Lead a team of 8 domestic and international Regulatory Affairs Managers.

• Lead all Advertising and Promotion review, engineering change notices, RA/QA assessments, internal

audits, and labeling. Serves as the primary strategic regulatory interface with the Product Development

Team.

• Serve as the Senior Regulatory Representative in executive management meetings consisting of cross

functional VPs.

• Review and approve all strategic regulatory documents used to support strategic regulatory discussions

with FDA.

• Serve as an interface with Legal Department for advertising & promotional matters and compliance

issues.

• Lead the LifeCell Warning Letter Due Diligence team and compile FDA responses.

• Oversee all domestic and international medical device and human tissue regulatory filings.

• Compile, review and approve all regulatory applications (IDEs, 510(k)s, TRG applications, etc.).

• Approve internal audit plans and ensure timely implementation/issuance of Quality Investigation and

CAPAs (Corrective and Preventive Actions).

• Participate/review all potential field action assessments and Health Hazard Evaluations (HHEs) and

provide risk evaluations recommendations to management.

• Serve as a primary liaison with FDA for all LifeCell interactions including regulatory filings, Warning

Letter correspondences, BIMO and QSIT inspections, and field actions.

• Lead inspections conducted by all domestic and international regulatory bodies (FDA, TGA, DEKRA,

and KFDA).

Sanofi-Aventis U.S. July 2008 to April 2011

Sr. Corporate Counsel

• Provide solution-oriented legal advice to the Cardiovascular (CV) and General Therapeutics (GT).

Business Units in support of multiple prescription drugs (Plavix, Avapro/Avalide, Nasacort, Xyzal,

Aplenzin, Eligard, Uroxatral, and Rilutek).

• Serve as the legal advisor on Advertising Review Committee meetings for CV and GT products

including new strategic concept reviews.

• Serve as the legal advisor for the Rapid Competitive Response team.

• Serve as the lead legal support to Medical affairs, Marketing, Regional Medical Liaisons, and

Regulatory Affairs departments.

• Serve as the legal advisor on regulatory labeling review meetings for various CV and GT products.

• Ensure company compliance with corporate policies and procedures, state and federal laws, and

regulations.

• Work closely with the CME department to assure timely review and approval of CV and GT grants.

• Draft, review and approve various types of agreements (i.e. non-disclosure, consultant, sponsorship,

commercial service, licensing and Investigator Initiated Studies).

• Conduct compliance training at speaker engagements for CV and GT products.

• Member of legal task force teams assigned to various department improvement projects.

• Partner with Corporate Compliance to analyze market research data for potential off-label promotional

practices.

• Attend Compliance investigational meetings and respond to inquiries on potential compliance

violations relating to Anti-kickback Statute, Fraud and Abuse, CIA, HIPAA, and FD&C Act for

marketed products.

Stryker Orthopedics October 2002 – July 2008

Director of Regulatory Affairs and Compliance

• Manage all regulatory filings for orthopedic products and oversee 20 regulatory affairs and compliance

specialists.

• Organize, prepare and review all 510(k)s, Investigational Device Exemptions, Premarket Approvals

(original/revision/supplements).

• Interface with International Organization for Standardization (ISO), CE marking, and Medical Device

Directive (MDD), Pharmaceutical Affairs Law (PAL) /Ministry of Health Labor & Welfare (MHLW)

and other international regulatory bodies.

• Direct interaction with FDA and international reviewers/inspectors.

• Serve as primary regulatory liaison for Stryker Japan and support all PAL/MHLW submissions.

• Review and approve FDA and international regulatory 510(K) and Design Dossier applications.

• Ensure that all labeling, marketing literature and training materials are reviewed for compliance to

regulatory requirements.

• Ensure that all changes to products and processes (including additions and deletions) are reviewed for

compliance to FDA, Quality System Regulations (QSRs), and affected international regulations.

• Manage Corrective Actions and Preventive Actions (CAPAs) and conduct risk assessments.

• Oversee regulatory recall actions and products tracking.

• Collaborate with the Compliance Officer to institute new policies, training, and procedures.

• Recruit, hire, train, manage, and develop Regulatory Affairs staff.

• Manage consultants and associated contracts for assigned regulatory projects.

• Implement and ensure compliance with HIPAA and ADVAMED policies.

Stryker Orthopedics

Clinical Operations Manager

• Manage 15 Data Managers (DMs), SAS programmers, Database Developers in support of all ongoing

clinical trials.

• Lead and conduct Study Team Meetings with representation from each line function for 15 orthopedic

projects.

• Present budget and resource summaries for various orthopedic projects.

• Conduct Manpower assessments to ensure proper Clinical Operations resources.

• Evaluate employee performance, conduct employee evaluations, recommend salary administrations,

and promotions.

Promotions: 12/07 (Directory of Regulatory Affairs and Compliance), 12/06 (Sr. Manager

Regulatory Affairs), 12/04 (Manager Regulatory Affairs)

President's Award 1/04

Recognition Award (stock options) 7/03, 7/05, 7/06, 3/08

Schering Plough Research Institute (SPRI) December 2000 - October 2002

Manager, Clinical Data Management

• Manage 10 Data Managers (DMs) and 40 ongoing Oncology Protocols.

• Lead and conduct Study Team Meetings with representation from each line function for 5 ongoing

oncology projects.

• Present budget and resource summaries to the Clinical Operations Review Committee (CORC) for

various oncology protocols.

• Attend various Study Team meetings and Therapy Drug Team meetings.

• Manage the review of listings and ensure the quality/accuracy of data in Final Summary Tables and

Listings used for Clinical Summary Reports (CSRs).

• Conduct vendor audits (EKG, eDiaries, EDC systems etc.) and submit audit reports.

• Attend and present electronic data capture implementation process at DIA conferences.

Awards: Schering Plough Excellence Award (December 2001)

Schering Plough Study Team Leader Recognition Award (May 2002)

Pfizer Pharmaceuticals, Inc. December 1997 - December 2000

Clinical Data Manager

• Develop and implement Data Management SOPs for Phase III and Phase IV trials.

• Serve as the Data Management Therapeutic Group Leader for CNS and GI areas supervising 4 clinical

data coordinators (CDCs).

• Manage, conduct audits, and establish Contract Research Organization (CRO) processes for

Biometrics outsourcing.

• Create a repository of edit checks, SOPs, and database conventions critical to data management

functionality.

• Participate in CRF design review, data quality planning, data review, and database finalization.

• Interact with CDC and Clinical Research Associates (CRA) to resolve and track database queries.

• Review, monitor, and reconcile SAEs between Safety Compliance Group database and project

database.

Janssen Pharmaceuticals (Johnson & Johnson) May 1996 - December 1997

Clinical Data Manager (consultant)

• Oversee all critical clinical study data management functions from initiation to closure of studies.

• Attend Oncology project team meetings and provide status reports on 10 CRO studies.

• Review and approve Clinical Database Structures and CRFs.

• Establish and develop SOPs for Clinical Research Organization (CRO) projects and document

processes.

Princeton Biomedical Research, PA June 1995 – May 1996

Clinical Research Coordinator

• Implement specific study protocol criteria and recruit potential subjects for studies.

• Complete patient CRFs and drug accountability logs in accordance to source

documentation.

• Serve as a liaison with pharmaceutical/CRO representatives.

Education: Admitted to New Jersey Bar 11/2003

Rutgers Law School, Camden, New Jersey

New York University, New York, New York

BA in Psychobiology

Honors: NYU College of Arts & Science Academic Scholarship

References: References shall be available upon request.

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