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REGULATORY AFFAIRS MANAGER (CMC SITE)

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...

CompanyBiospace
AddressNew Albany, OH
CategoryInformation Technology
Job typeFull time
Date Posted just now See detail

Regulatory Affairs Manager (CMC Site) New

Biospace

New Albany, OH

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...

just now seen See more...

US Associate Director Payer & Access Strategy, Medical Affairs, Oncology (Remote) New

Merck

Rahway, NJ

The US Associate Director Payer & Access Strategy Lead, Medical Affairs (US AD PASL) role supports the Global Medical and Scientific Affairs (GMSA) strategic priority "Invest in the growth, success and well-being of our people" an...

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Medical Affairs Manager – Pharmaceuticals

Baxter

Deerfield, IL

$120,000 - $165,000 a year

Executing on the defined Medical Affairs strategy Collaborating with marketing and sales teams to support product launches and therapy campaigns Serving as a subject matter expert and providing training internally and externally w...

a month ago seen See more...

Medical Affairs Operations Senior Manager-Americas (Hybrid)

Csl

Summit, NJ

Provide Medical Affairs (MA) project support regionally and engage team members to solicit project concerns and ideas for improvement. . Meet with MA Regional Head and Country Medical Leads to provide MA project status updates and...

6 days ago seen See more...

Medical Strategy & Operations Manager - Performance Management New

Biospace

Washington, DC

Leads and facilitates operational activities to plan, build, implement, launch and maintain the capability in accordance with strategy, vision, goals & roadmap. Owns the build/ assessment/ maintenance of the end to end capability...

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Associate Director, Medical Affairs - Program Management

Merck

Rahway, NJ

Support the SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines are consistently met.. Facilitate the creation and approval of all project deliverables, including maintaining d...

2 weeks ago seen See more...

MetroPlusHealth Summer Internship: Behavioral Health/Medical Management New

Metroplushealth

New York, NY

Note: This is a paid internship program. Prospective interns must be current students attending an accredited College or University and must be 18 years or older to be considered.. Learn how to summarize a members behavioral and...

5 hours ago seen See more...

Global Medical Affairs Leader, Gastroenterology New

Johnson & Johnson

United, PA

Development of Medical Affairs Strategy and plan for the assigned compounds based on global and prioritized regional needs. Working with the CDT to ensure integration with the overall global compound strategy, resulting in one g...

10 hours ago seen See more...

Clinical Trial Manager, Global Oncology Medical Affairs

Biospace

Basking Ridge, NJ

Support the preparation, set-up, and execution and reporting of all Global Oncology Medical Affairs operations Clinical Trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP G...

3 weeks ago seen See more...

Associate Manager, Regulatory Affairs (Hybrid) New

Iff Family Of Companies

Hazlet, NJ

Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...

10 hours ago seen See more...

Manager, Reg Affairs NAM New

Iff Family Of Companies

Ridgefield, NJ

Responsible for the preparation of regulatory submissions including GRAS dossiers, NDIN, Master Files, FSRN and other relevant regulatory documents or submissions. Collaborate with internal IFF Global Regulatory Strategy Lead and...

10 hours ago seen See more...

Manager, Global Regulatory Affairs CMC New

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

13 hours ago seen See more...

Manager, Regulatory Affairs- North America (Hybrid)

Iff Family Of Companies

Hazlet, NJ

Mentoring and working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulator...

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Senior Project Manager, Medical Affairs

Astellas

Northbrook, IL

Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration...

4 weeks ago seen See more...

Senior Project Manager, Medical Affairs

Astellas Pharma, Inc.

Northbrook, IL

Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration...

4 weeks ago seen See more...

Manager 1 - Medical Affairs (contract)

Jnj

Remote

$111K - $141K a year

Collaborate with internal and external experts to generate rigorous scientific data, and contribute to development of dissemination plans, as aligned with the Integrated Evidence Team (IET), to support the RWV&E strategic plans fo...

a month ago seen See more...

Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California (Hybrid)

Beautyhealth

Long Beach, CA

$130,000 - $150,000 a year

Lead all Regulatory Affairs projects to ensure compliance with all international, federal, state, and local facility/product registration, licensing, and reporting requirements for cosmetics and medical devices. Support in managin...

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Manager/Sr. Manager, Medical Affairs

Zentalis

New York, NY

Alongside Medical Affairs leadership, work to achieve corporate goals while keeping in compliance with policies and regulations. Create the process, plan, and manage the development and submission of medical and scientific publica...

a month ago seen See more...

Senior Manager, Scientific Communications, Medical Affairs

Edwards Lifesciences

Boise, ID

The mission of the Transcatheter Heart Valve (THV) Medical Affairs organization is to foster internal and external collaborations to generate and disseminate evidence-based best clinical practices to help save patients' lives and...

2 months ago seen See more...

Business Affairs Manager

Walt Disney World Resort

Lorida, FL

Lead and draft contracts. Maintain business practices and standards compliance. Prepare and manage contracts. Collaborate with stakeholders on deal terms. Review marketing collateral and new business initiatives. Detail Oriented:...

4 days ago seen See more...

Regulatory Affairs Sr Manager (Medical Device)

Connexion Systems & Engineering, Inc.

Westford, MA

Responsible for the oversight of Regulatory Affairs as directed. Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary. Manages the collection and coordination of in...

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Scientific Director, Medical Affairs

Iovance Biotherapeutics Inc

Sylvania, PA

Represent Iovance Medical Affairs as a TIL cell therapy expert in both internal and external venues including the US and Global cross-functional teams, internal medical review meetings, Peer-to-Peer consults, clinical sub-teams, a...

5 days ago seen See more...

Care Management Assistant - Healthpark Medical Center

Lee Physician Group

Lorida, FL

Strong clerical and customer service skills. Willingness to work in a hospital environment and assist the Care Management department. Ability to prioritize. Comfortable navigating electronic records. High School Diploma or Equival...

2 days ago seen See more...

Manager/ Sr. Manager Medical and Scientific Writer

Biospace

Malvern,

Author and analyze technical data pertinent to clinical operations, including CMC, non-clinical toxicology, and pre-clinical efficacy data, to support the development of regulatory documents such as Pre-INDs, INDs, BLAs, and IMPDs...

2 days ago seen See more...

Manager, CMC Regulatory Affairs - Remote OR West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...

2 days ago seen See more...

Manager - Independent Medical Education

Biospace

Plainsboro, NJ

Apply clinical knowledge and strategic thinking to develop and execute annual IME strategy that aligns with Novo Nordisks business priorities and external educational needs in collaboration with internal stakeholders. Review assi...

2 days ago seen See more...

Lab Tech/Manager - Department of Neurology - Georgetown University Medical Center

Georgetown University

Washington, United States

Coordinating research involving stroke patients and healthy volunteers. Assisting with experimental design, programming, experiment setup, and data analysis. Conducting behavioral, fMRI, and brain stimulation experiments in stroke...

3 days ago seen See more...

Senior Manager, Product Communications and Public Affairs, Pulmonary Hypertension

Johnson & Johnson

Titusville, NJ

Develop and implement innovative communication and Public Affairs strategies and programs in support of brand business objectives for UPTRAVI, OPSUMIT, OPSYNVI. Lead the growth of unbranded social communities and content creat...

3 days ago seen See more...

Scientific Director, Medical Affairs- CNS/Psychiatry

Biospace

Florham Park, NJ

Develops and initiates Medical Affairs activities, generation and dissemination of data supporting the overall scientific strategy. Lead or provide input into the design, analysis, interpretation, and reporting of scientific and m...

6 days ago seen See more...

Associate Director, Field Medical Affairs- Hematology (Chicago area)

Biospace

Chicago, IL

Want to be a part of a pre-launch stage Field Medical team a with potential for multiple launches.. Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt ap...

6 days ago seen See more...

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