CMC Regulatory Consultant jobs in United States
cer-icon
Apply on Employer Site
company-logo

Redbock - an NES Fircroft company ยท 15 hours ago

CMC Regulatory Consultant

positionUnited States
timePart-time
remoteRemote
senioritySenior Level

Redbock, an NES Fircroft company, is seeking a CMC Regulatory professional to provide labeling guidance and support for their innovative life sciences team. The role involves offering subject matter expert guidance on regulatory-compliant label templates and blinding compliance for clinical trials.

BiotechnologyConsultingMedical DevicePharmaceutical
check
Growth Opportunities
check
H1B Sponsor Likelynote
Hiring Manager
Kalyn Burer
linkedin

Responsibilities

Provide SME guidance for regulatory-compliant label templates for kits, vials, and comparators
Provide SME guidance related to blinding compliance
Related team correspondence and communications
Other duties, as required

Qualification

Investigational Medical Product labelingICHFDA GCP guidelinesClinical Supply Chain understandingDouble dummy clinical study designRelevant degree

Required

Expert in Investigational Medical Product labeling for U.S. blinded clinical trials
Expert in both ICH and FDA GCP labeling requirements and guidelines
Solid understanding of Clinical Supply Chain matters and consideration for labeled products
Experience with double dummy clinical study designs and associated randomization numbers
Relevant degree

Company

Redbock - an NES Fircroft company

twittertwittertwitter
company-logo
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
dateFounded in 2010
location
Cupertino, California, USA
people-size51-200 employees
web-link
http://redbock.com/

H1B Sponsorship

Redbock - an NES Fircroft company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2018-06-20Acquired
Company data provided by crunchbase