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Jennie Meeker

Jennie Meeker

Head, Regulatory Affairs and Pharmacovigilance - Canada

Novartis Animal Health

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Head, Regulatory Affairs and Pharmacovigilance - Canada at Novartis Animal Health

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Novartis Animal Health

Head, Regulatory Affairs and Pharmacovigilance - Canada

Provide leadership and management to the Regulatory Affairs and Pharmacovigilance team (direct/indirect reports). Lead regulatory strategy development and ensure regulatory and pharmacovigilance compliance. Act as company liaison to Health Canada, Canadian Food Inspection Agency, and other health authorities for defining registration and compliance requirements. Member of Management Team. Represent Division on Novartis Canada Public Affairs Council (PAC). Represent company in trade associations. Division Road2Hope Team Lead 2013. 2013 Training: IMPACT Program; Finance for Non-Finance Managers; Washington, DC Immersion Program

Career medium 05
Career
Career medium 05

Novartis Animal Health

Head, Regulatory Affairs Canada

Provide leadership to the Canadian Regulatory Affairs team (5 direct reports including contingents) in pharmaceutical, biologics, and pesticide projects. Lead regulatory strategy development and ensure regulatory and pharmacovigilance compliance. Serve as in-country pharmacovigilance leader. Act as company liaison to Health Canada, Canadian Food Inspection Agency, and other health authorities for defining registration and compliance requirements. Member of Management Team. Represent Division on Novartis Canada Public Affairs Council. Represent the company in trade associations. NAHCI Road2Hope Team Lead 2013

Career

Novartis Animal Health

Senior Regulatory Affairs Manager

Manage regulatory aspects of pharmaceutical and pesticide projects/products, including the preparation and submission of dossiers, to regulatory agencies. Represent the regulatory function on global and regional project teams, providing regulatory expertise and strategy input to ensure effective business outcomes. Proactively develop and implement effective regulatory strategies for product development. Provide interpretive analyses of complex regulatory guidance documents, regulations, and directives that impact business. Cross-functional teamwork with New Product Development and Marketing. Manage direct reports. Interim Head Regulatory Affairs, Canadian Business Nov. 2011 – Mar 2012. Novartis Leading at the Front Line training program 2011.

Career medium 06
Career
Career medium 04

AstraZeneca

Regulatory Affairs Manager

Provide regulatory strategy to teams and management to prepare filing of New Drug Application (NDA) within oncology therapeutic area. Provide support to global regulatory affairs in the facilitation of regulatory functions as part of a global cross-functional team. Monitor and advise team members and product managers of upcoming regulatory affairs deadlines. Proactively solicit regulatory submittals from other departments. Prepare and submit packages to applicable agencies and liaise with agencies. Interact with regulatory affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions. Committee Director – AZ Network of Women Professional Development Committee – Wilmington chapter (2010).

Career

Intervet/Schering-Plough Animal Health

Manager, Regulatory Affairs

Manage regulatory aspects of projects/products, including the preparation and submission of regulatory related documents, including INAD and NADA filings, to regulatory agencies. Coordinated US regulatory affairs activities and team in merger. Represent the regulatory function on global and national project teams, providing regulatory expertise and strategy input to ensure effective business outcomes. Proactively develop and implement effective regulatory strategies for product development. Provide interpretive analyses of complex regulatory guidance documents, regulations, and directives that impact business. Cross-functional teamwork with Pharmaceutical Research, Drug Discovery, Project Management, and Marketing. Post-approval labeling, advertising and promotional materials review.

Career medium 02
Career
Career medium 06

Crowell & Moring LLP

Senior Associate, C&M Capitolink

Provided expert advice and recommendations to clients on technical, regulatory policy and legislative policy issues. Worked with teams of researchers and industry representatives on innovative market-based and voluntary solutions to meet client needs. Developed and implemented strategic plans, technical and policy advisories, and communications. Developed new client relationships and business opportunities. Liaised with Members of Congress and U.S. Federal Government Agencies to advance clients’ issues. Clients included multi-national corporations, companies, and trade associations in the agribusiness industry.

Career

American Frozen Food Institute

Manager

Developed and disseminated federal regulatory policy and legislative policy information to member companies. Liaised with Members of Congress and U.S. Federal Government Agencies on behalf of member companies.
Compiled and produced the Institute’s semi-annual and annual statistics reports. Managed activities of member-composed statistics, regulatory, legislative, and environment committees, and food industry coalition. Represented and provided regulatory assistance to AFFI managed organizations including the International Frozen Food Association, National Frozen Pizza Institute, and National Yogurt Association.

Career medium 01
Career

Virginia Polytechnic Institute and State University

MPA, Public Administration and Policy

The Ohio State University

MS, Animal Science

Colorado State University

BS, Animal Science

Arickaree

Virginia Polytechnic Institute and State University

PhD Candidate, Public Administration and Policy