Regulatory Affairs Consultant
redbock an nes fircroft companyFort Worth (TX)
Regulatory Affairs Consultant
Posted yesterday
redbock an nes fircroft companyFort Worth (TX)
SENIORITY
Senior
About the role
CMC Regulatory Consultant (6-12 Month Contract // REMOTE) Part-time - 10-20+ hours per weekSummary: CMC Regulatory Expert needed to support INDa submission activities and related responsibilitiesDuties & Responsibilities: Provide Subject Matter Expert-level guidance for submission structure and contentReview submission draft for Module 3 compliance, overall accuracy and completeness, and provide overall CMC regulatory strategy guidanceProvide general feedback for IND filing and amendmentsCollaboration with internal stakeholders and other related personnelProvide submission readiness sign-offOther duties, as requiredQualifications & Requirements: Solid experience CMC Regulatory strategy, content and authoring expertise for viral vector or microbial systems Phase II INDa submissionsExtensive track record of managing, authoring and editing multiple FDA regulatory submissionsStrong understanding of biologics Chemistry, Manufacturing and Controls and related complianceExcellent written, verbal and interpersonal communication skillsRelevant degreeLocation: Work can be performed remotely from home
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.