77 applicants
ReCode Therapeutics · 3 days ago
Regulatory Operations/Project Management Consultant
Menlo Park, CA
Part-time, Contract
Onsite
Senior Level
$85/hr - $115/hr
5+ years exp
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Responsibilities
Coordinate and review regulatory submissions for global and US markets, including INDs and CTAs, and annual reports, in collaboration with regulatory lead and cross-functional teams.
Develop and maintain regulatory documents, such as cover letters, FDA forms, administrative information, and letters of authorization, for submission to regulatory agencies.
Support regulatory meeting preparation, including scheduling meetings, preparing agendas, tracking action items, and coordinating responses to regulatory inquiries.
Maintain regulatory tracking systems, including health authority query (HAQ) trackers, and archive regulatory correspondences in compliance with internal standards.
Collaborate with cross-functional teams, including CMC, Translational, Clinical, Quality, and Program Management, to ensure accurate and timely execution of regulatory plans.
Participate in internal and external project team meetings, prepare meeting materials, and document meeting minutes to facilitate project progress and decision-making.
Stay updated on relevant regulatory guidelines, industry trends, and best practices to contribute to continuous process improvement within the regulatory affairs function.
Qualification
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Required
Bachelor's degree in a scientific discipline, preferably with an advanced degree (e.g., MS, PharmD, Ph.D.) in a related field.
Minimum of 5 years of overall related experience, with at least 2 years of industry experience within regulatory affairs project management.
Knowledge of global regulatory requirements, including FDA (CBER), EMA, MHRA, and other major regulatory authorities
Highly organized, detail-oriented, and capable of managing multiple projects and priorities simultaneously.
A collaborative mindset with the ability to work effectively in a cross-functional, fast-paced environment.
Benefits
No premium cost for employees - 100% subsidized by ReCode for full-time employees
Company 401k contribution
15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
Mental health support for employees & their families
FSA available, including a lifestyle spending account subsidized by company
Employee discounts at hotspots
Company
ReCode Therapeutics
ReCode Therapeutics is a genetic medicines company that specializes in mRNA and gene correction therapeutics.
11-50 employees
H1B Sponsorship
ReCode Therapeutics 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
Trends of Total Sponsorships
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$342MKey Investors
Bioluminescence VenturesCystic Fibrosis Foundation
2023-09-19Series B· $50M
2023-01-10Series Unknown· $10M
2022-06-29Series B· $120M
Leadership Team
Shehnaaz Suliman
CEO & Board Member
Philip Thomas
Co-Founder
Recent News
2024-05-23
Company data provided by crunchbase
