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Proclinical Staffing · 4 hours ago

RA Consultant

positionSan Francisco County, CA
timeFull-time
remoteOnsite
seniorityDirector/Executive
money$175/hr - $250/hr

Proclinical Staffing is seeking an Associate Director or Director of Regulatory Affairs to join a cutting-edge biotech team. The role involves developing and executing global regulatory strategies for clinical development programs, particularly focused on virology assets.

Staffing & Recruiting
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H1B Sponsor Likelynote
Hiring Manager
Alex Bill
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Responsibilities

Develop and implement global regulatory strategies aligned with clinical development plans
Lead the preparation, review, and submission of regulatory filings, including IND/CTA amendments and briefing packages
Act as the primary regulatory contact for health authority interactions and meetings
Provide regulatory guidance to cross-functional teams, including Clinical, CMC, Nonclinical, and Quality teams
Monitor regulatory intelligence and assess its impact on development programs
Support regulatory aspects of clinical trial execution and lifecycle management
Manage external vendors and consultants as needed
Ensure compliance with applicable global regulations and guidelines

Qualification

Regulatory AffairsClinical-stage submissionsFDA knowledgeEMA knowledgeLife sciences degreeCollaboration skillsCommunication skills

Required

Advanced degree in life sciences or a related field (PhD, PharmD, MD preferred; MS with strong experience considered)
Experience in Regulatory Affairs within biotech or pharmaceutical industries
Proven expertise in clinical-stage regulatory submissions
Strong knowledge of FDA and EMA regulatory frameworks
Ability to work independently while effectively collaborating across teams
Excellent written and verbal communication skills

Company

Proclinical Staffing

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At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
dateFounded in 2005
location
City of London, London, GB
people-size51-200 employees
web-link
http://www.proclinical.com

H1B Sponsorship

Proclinical Staffing 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
2024 (1)
2023 (1)
2022 (1)
2021 (1)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase