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Run my Accounts AG
Indianapolis, IN, United States
Location Greater Boston or Indianapolis area Role Description Acumen Pharmaceuticals is seeking an experienced and dynamic Vice President, Head of Regulatory Affairs to lead our regulatory strategy and ensure the successful development and commercialization of our Alzheimer's disease therapies. Reporting to the Chief Development Officer, the suc
Job Source: Run my Accounts AGFresenius Kabi USA, LLC
Indianapolis, IN, 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, LLCIndiana Wesleyan University
Indianapolis, IN, United States
Assistant Vice President of Academic Affairs Apply now Job no: 493863 Work type: Administrative (Full Time) Location: Indianapolis, IN, Hybrid (2 Office / 3 Remote), Remote (within United States) Categories: Administrative/Professional Job Title: Assistant Vice President of Academic Affairs Reporting Relationship: Vice President of A
Job Source: Indiana Wesleyan UniversityIndiana Wesleyan University
Indianapolis, IN, United States
Assistant Vice President of Academic Affairs Job no: 493863 Work type: Administrative (Full Time) Location: Indianapolis, IN, Hybrid (2 Office / 3 Remote), Remote (within United States) Categories: Administrative/Professional Job Title: Assistant Vice President of Academic Affairs Reporting Relationship: Vice President of Academic Affairs
Job Source: Indiana Wesleyan UniversityIndiana Wesleyan University
Indianapolis, IN, United States
Assistant Vice President of Academic Affairs Job no: 493863 Work type: Administrative (Full Time) Location: Indianapolis, IN, Hybrid (2 Office / 3 Remote), Remote (within United States) Categories: Administrative/Professional Job Title: Assistant Vice President of Academic Affairs Reporting Relationship: Vice President of Academic Affairs
Job Source: Indiana Wesleyan UniversityEiteljorg Museum of American Indians and Western Art
Indianapolis, IN, United States
A Diverse Staff of Dedicated and Passionate People The Eiteljorg Museum seeks to attract, recruit, and support a diverse staff of talented people. We offer competitive packages and practice equal opportunity employment policies. In this section, find listings for any open positions. Vice President of Curatorial Affairs and Collections The Eitelj
Job Source: Eiteljorg Museum of American Indians and Western ArtEli Lilly
Indianapolis, IN, United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our commun
Job Source: Eli LillyIvy Tech Community College of Indiana
Indianapolis, IN, United States
Company name Ivy Tech Community College of Indiana Location Indianapolis, IN, United States Employment Type Full-Time Posted on Mar 15, 2023 Valid Through Jun 28, 2023 Apply for this job your email: upload resume: Profile Work type: Full Time Administrative Location: Systems Office - Indianapolis, IN Categories: Administrative/Professional
Job Source: Ivy Tech Community College of IndianaIndianapolis, IN, United States
Vice President, Regulatory Affairs
About the Company
Innovative biotechnology company specializing in Alzheimer's disease therapeutics & diagnostics
Industry
Biotechnology
Type
Public Company
Founded
1996
Employees
51-200
Categories
Biotechnology
Pharmaceuticals
Academic Research
Health Care
Medical Care
Medical Conditions
Therapeutics
Medical Diagnostics
Medicines
Life Sciences
Medicine
Manufacturing
Chemical Products
Specialties
Alzheimer's disease
Neurodegenerative disease
therapeutics
amyloid-beta oligomers
monoclonal anitbodies
and immunotherapy
About the Role
The Company is in search of a Vice President, Regulatory Affairs to spearhead the development and execution of global regulatory strategies for its innovative therapies. The successful candidate will be at the forefront of shaping the regulatory roadmap, engaging with authorities such as the FDA and EMA, and driving the approval process for the company's portfolio, with a specific focus on CNS. This pivotal role demands a leader with an advanced degree in a relevant scientific discipline, a minimum of 10 years' experience in regulatory affairs within the biotech or pharmaceutical industry, and a proven track record in shepherding regulatory activities for novel treatments. Responsibilities include leading the preparation and submission of a range of regulatory documents, proactively identifying and addressing regulatory risks, and ensuring compliance with evolving guidelines and industry standards. The role also involves providing strategic guidance to cross-functional teams, advising on clinical study design, and overseeing the development of regulatory policies and best practices. The ideal candidate will have extensive experience in regulatory submissions, interactions, and approvals, and a strong ability to influence both internal and external stakeholders. While not mandatory, regulatory affairs certification (RAC) is desirable. The Vice President will also be expected to build and mentor a team of regulatory professionals, as well as engage with external partners to enhance regulatory strategy and execution. This is a unique opportunity to be part of a company at the forefront of Alzheimer's disease research, with a focus on a novel therapeutic approach.
Hiring Manager Title
Chief Development Officer
Travel Percent
Less than 10%
Functions
Operations
Strategy
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Email Alert for Vice President, Regulatory Affairs jobs in Indianapolis, IN, United States
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