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Fresenius Kabi USA, LLC
Baltimore, MD, United States
Job Summary The Vice President, Medical Affairs is responsible for leading the development and execution of strategic and tactical plans for Headquarter (HQ) and Field medical affairs teams pre-launch, launch, and post approval for biosimilars and biologic products. This leader is an active and collaborative member of the Biosimilar Leadership Team
Job Source: Fresenius Kabi USA, LLCBiomatrica
Baltimore, MD, United States
Summary of Major Responsibilities: The Regulatory Affairs Manager position is responsible for the preparation of regulatory submissions required to market in vitro diagnostic devices in both domestic and international markets. This position requires the development, execution, and management of procedures to ensure that the product development pro
Job Source: BiomatricaLviassociates
Baltimore, MD, United States
Job Opportunity: Vice President - Geotechnical Engineering Location: Baltimore, USA Are you ready to take your career to the next level? Join our client in Maryland, a pioneering company managed by professional engineers and scientific experts. We are dedicated to setting the industry standard for excellence through our commitment to education, kn
Job Source: LviassociatesBridgeTower Media
Baltimore
Job Description Job Description This reporting position is responsible for covering civil litigation filings and criminal law cases in our core readership areas. This reporter will be responsible for news pertaining to settlements and verdicts in these cases, with a particular focus on cases that have broader significance in the legal system and
Job Source: BridgeTower MediaCapitol Technology University
Laurel
Job Description Job Description Department Chair Construction Management Full-time, 12-Month, Exempt Position Capitol Technology is a small, private, non-profit, university in South Laurel, Maryland with approximately 900 students and a dedicated full-time staff of 75. POSITION DESCRIPTION : This position will provide leadership in the a
Job Source: Capitol Technology UniversityDaiichi Sankyo
Baltimore, MD, United States
Director, US Regulatory Affairs Strategy in Basking Ridge at Daiichi Sankyo Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world
Job Source: Daiichi SankyoDaiichi Sankyo
, MD, United States
Director, US Regulatory Affairs Strategy in Basking Ridge at Daiichi Sankyo Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our w
Job Source: Daiichi SankyoTRIUM Clinical Consulting NV
, MD, United States
Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. We help with the implementation
Job Source: TRIUM Clinical Consulting NVBaltimore, MD, United States
Vice President, Legal & Regulatory Affairs
About the Company
Premier provider of life science tools
Industry
Biotechnology
Type
Public Company
Founded
1998
Employees
5001-10,000
Categories
Biotechnology
Genetics
Medical
Consulting & Professional Services
Biochemistry and Molecular Biology
Bioinformatics
Biology
Gene Expression
Health Care
Healthcare
Manufacturing
Medical Devices & Equipment
Pharmaceutical Industry
Pharmaceuticals
Science
Test & Measurement Equipment
Business Classifications
B2B
SAAS
Enterprise
About the Role
The Company is seeking a VP, Legal - Regulatory Affairs to join their dynamic team. The successful candidate will be at the forefront of expanding access to genomic technology, with a focus on realizing health equity for a global population. This role is pivotal in enabling life-changing discoveries that transform human health, particularly in the early detection and diagnosis of diseases, and the development of new treatment options. The VP, Legal - Regulatory Affairs will be responsible for setting the legal vision, mission, and strategy for regulatory affairs, and will play a key role in managing complex internal and external legal issues, both regionally and globally. Key responsibilities for this position include providing strategic and practical legal counsel on a wide range of drug and medical device development legal and regulatory issues, collaborating with internal clients and legal department colleagues across different countries and departments, and maintaining a positive leadership image. The ideal candidate will have a J.D. or LL.M. degree from an ABA-accredited law school, admission to practice law in a U.S. jurisdiction, and at least 15 years of experience practicing law, with a focus on biotechnology, pharmaceutical, medical device, and/or healthcare. Experience working with the FDA and a strong understanding of the laws and regulations related to the discovery, development, approval, sales, and marketing of biotechnology, pharmaceutical, and medical device products are essential. Excellent interpersonal skills, the ability to manage diverse issues, and a strong research and writing background are also required.
Hiring Manager Title
General Counsel
Travel Percent
Less than 10%
Functions
Legal
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Email Alert for Vice President, Legal & Regulatory Affairs jobs in Baltimore, MD, United States
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