Regulatory Affairs Biosimilars Per Diem Consultant jobs in United States
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Pharmavise Corporation ยท 1 month ago

Regulatory Affairs Biosimilars Per Diem Consultant

positionUnited States
timeContract
remoteRemote
senioritySenior Level, Lead/Staff
date8+ years exp

Pharmavise Corporation is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. They are seeking skilled professionals to provide expert regulatory affairs guidance and support for biosimilars development projects.

Food and BeverageHealth Care

Responsibilities

Provide expert regulatory affairs guidance and support for biosimilars development projects
Review and analyze regulatory requirements and guidelines related to biosimilars in various regions
Assist in the preparation, submission, and maintenance of regulatory submissions for biosimilars, including INDs, BLAs, and variations
Collaborate with cross-functional teams to ensure alignment on regulatory strategy and objectives
Stay updated on regulatory developments and trends impacting biosimilars globally
Participate in meetings with regulatory authorities as needed
Provide regulatory support and expertise during regulatory agency inspections and audits

Qualification

Regulatory affairs expertiseBiosimilars knowledgeRegulatory submissions experienceRegulatory affairs certificationCommunication skillsInterpersonal skillsProject management

Required

Bachelor's degree in a scientific or related field; advanced degree preferred
Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with specific expertise in biosimilars preferred
Strong understanding of regulatory requirements and guidelines governing biosimilars development and approval processes
Experience with regulatory submissions for biosimilars, including INDs, BLAs, and variations
Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders
Proven ability to work independently and manage multiple projects simultaneously

Preferred

Advanced degree preferred
Specific expertise in biosimilars preferred
Regulatory affairs certification (RAC) preferred but not required

Benefits

Competitive compensation packages are available.

Company

Pharmavise Corporation

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โ™ฆ๐„๐ฑ๐œ๐ž๐ฅ๐ฅ๐ž๐ง๐œ๐ž ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐š๐ฅ๐ข๐ญ๐ฒโ™ฆ: ๐๐ก๐š๐ซ๐ฆ๐š๐ฏ๐ข๐ฌ๐ž, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ข๐œ ๐‹๐ข๐Ÿ๐ž ๐’๐œ๐ข๐ž๐ง๐œ๐ž๐ฌ, ๐‡๐ž๐š๐ฅ๐ญ๐ก๐œ๐š๐ซ๐ž ๐š๐ง๐ ๐†๐จ๐ฏ๐ž๐ซ๐ง๐ฆ๐ž๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐š๐ซ๐ญ๐ง๐ž๐ซ.
dateFounded in 2013
location
Coral Springs, Florida, USA
people-size11-50 employees
web-link
http://www.pharmavise.com

Funding

Current Stage
Early Stage
Total Funding
unknown
2020-04-04Seed

Leadership Team

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Ricardo Joseph
Founder and CEO
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Company data provided by crunchbase