- 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.
- 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.
- 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
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Regulatory Project Management Consultant - Menlo Park, United States - ReCode Therapeutics, Inc
4 weeks ago
Description
Who We Are:
ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode's lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.
Summary of Position:
ReCode is seeking a Regulatory Project Management Consultant to play a critical role in coordinating and managing regulatory activities to support global drug development programs. This position requires a detail-oriented professional with strong project management skills and regulatory expertise to ensure compliance with regulatory requirements and successful execution of regulatory strategies. This is a part-time contract position (likely 20-25 hours/week) that can be remote with a strong preference for west coast location (PST time zone).
Responsibilities:
Qualifications:
Salary Range: *$85-$115/hr
*Please note that for remote positions, salary may be adjusted for cost of living
Benefits Offered for Full-Time Employees:
ReCode Therapeutics ) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.
