Regulatory Operations/Project Management Consultant

1 month ago

Menlo Park, California, United States ReCode Therapeutics Full time

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 Operations/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:

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.

Qualifications:
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.

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:

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

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.

  • Lead Technical Project Manager

    7 days ago

    Menlo Park, California, United States TEKsystems Full time

    Position Overview:The Technical Project Manager for the Compliance & Privacy team plays a crucial role in steering significant projects aimed at safeguarding user privacy and adhering to global regulations concerning messaging and calling, collaborating with various stakeholders across the organization.Role Summary:This position is pivotal at the...

  • Senior Technical Project Manager

    7 days ago

    Menlo Park, California, United States TEKsystems Full time

    Position Overview:The Technical Project Manager for the Compliance & Privacy division plays a pivotal role in steering essential projects aimed at safeguarding user privacy and adhering to global regulations concerning messaging and calling, collaborating with stakeholders across the organization.Role Summary:This position operates at the crossroads of...

  • Project Manager, Land Use

    1 month ago

    Menlo Park, California, United States Stanford Health Care Full time

    If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. Day - 08 Hour (United States of America)This is a Stanford Health Care job.A Brief OverviewThe Land Use & Licensing Project Manager supports the Hospitals' land use and...

  • Privacy Compliance Project Leader

    7 days ago

    Menlo Park, California, United States TEKsystems Full time

    Position Overview:The Technical Project Manager for the Compliance & Privacy division plays a pivotal role in steering significant projects aimed at safeguarding user privacy and adhering to global regulations related to messaging and calling. This position collaborates with various stakeholders across the organization.Role Summary:The Compliance/Privacy TPM...

  • Privacy Compliance Project Leader

    7 days ago

    Menlo Park, California, United States TEKsystems Full time

    Position Overview:The Technical Project Manager for the Compliance & Privacy team plays a crucial role in steering significant projects aimed at safeguarding user privacy and adhering to global regulations concerning messaging and calling, collaborating with stakeholders across the organization.Role Summary:This position requires the TPM to navigate the...

  • Project Management Specialist

    4 days ago

    Menlo Park, California, United States Ekman Associates Full time

    About Ekman AssociatesEkman Associates, Inc. is a Southern California-based company specializing in Management Consulting, Professional Staffing Solutions, Executive Recruiting, and Managed Services.Job SummaryWe are seeking a highly skilled and motivated Technical Program/Project Manager to oversee multiple programs/projects and drive results. This role is...

  • Senior Manager

    1 week ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job OverviewPosition SummaryThe Senior Manager of Medical Information (MI) will play a pivotal role in the establishment and enhancement of various systems and processes that underpin MI. This position emphasizes project management, process development, standard operating procedure (SOP) formulation, training initiatives, and the creation of MI...

  • Senior Technical Project Leader

    7 days ago

    Menlo Park, California, United States TEKsystems Full time

    Position Overview:The Technical Project Manager for the Compliance & Privacy team is responsible for spearheading critical initiatives aimed at safeguarding user privacy and adhering to global regulations concerning messaging and calling, collaborating with stakeholders across the organization.Role Summary:This position serves as a pivotal link between...

  • Senior Manager, Facilities Operations

    2 days ago

    Menlo Park, California, United States Mainspring Energy, Inc. Full time

    About Mainspring Energy, Inc.Mainspring Energy, Inc. is a pioneering company in the field of power generation, dedicated to developing innovative solutions for a sustainable and reliable energy future. Our mission is to accelerate the transition to a net-zero carbon grid, and we're looking for talented professionals to join our team.Job SummaryWe're seeking...

  • Project Director

    9 hours ago

    Menlo Park, California, United States SPARK NS Full time

    About the Organization:SPARK NS is a pioneering non-profit translational research organization dedicated to accelerating the translation of promising neuroscience discoveries from the lab to the clinic. Our mission is to bridge the gap between basic research and drug development, providing a platform for academic principal investigators to advance their...

  • Financial Operations Manager

    1 week ago

    Menlo Park, California, United States Stanford Children's Health | Lucile Packard Children's Hospital Stanford Full time

    Job SummaryThis position is responsible for assisting departmental leadership in organizational development, benchmarking, operational reporting, management reporting, performance management, measuring trends, budgeting, analysis, and other financial activities with a limited functional or organizational scope.Key Responsibilities:Assists the director in...

  • Privacy Compliance Project Lead

    2 weeks ago

    Menlo Park, California, United States TEKsystems Full time

    Position Overview:The Technical Project Manager for the Compliance & Privacy division plays a pivotal role in steering significant projects aimed at safeguarding user privacy and adhering to global regulations in messaging and calling. This position collaborates with various stakeholders across the organization.Role Summary:The primary responsibility of the...

  • Facilities Management Leader

    2 days ago

    Menlo Park, California, United States SBM Management Services Full time

    About the RoleWe are seeking a highly skilled and experienced Custodial Supervisor to join our team at SBM Management Services.Key ResponsibilitiesOversee Custodial Program: Ensure the effective management of all custodial activities, including the implementation of safe work practices and procedures.Coordinate Work Activities: Monitor and coordinate the...

  • Associate Chief Operations Officer

    2 weeks ago

    Menlo Park, California, United States SLAC National Accelerator Laboratory Full time

    In this pivotal role, you will assist the Deputy Laboratory Director for Operations and the Chief Operating Officer (COO) in steering the development and execution of strategic initiatives, policies, and operational duties. Collaborating closely with various programmatic sectors of the laboratory, you will enhance world-class operational support that aligns...

  • Custodial Operations Manager

    9 hours ago

    Menlo Park, California, United States SBM Management Services Full time

    About the RoleWe are seeking a highly skilled and experienced Custodial Supervisor to join our team at SBM Management Services. As a key member of our facilities management team, you will be responsible for overseeing the daily operations of our custodial services, ensuring that our facilities are clean, safe, and well-maintained.Key...

  • Senior IT Operations Manager

    2 weeks ago

    Menlo Park, California, United States Genesys Cloud Services, Inc. Full time

    Genesys Cloud Services, Inc. is a leader in enhancing customer and employee experiences for over 8,000 organizations worldwide. Our flagship platform, Genesys Cloud, is recognized as the premier AI-driven experience orchestration solution, empowering businesses of all sizes to deliver personalized and empathetic interactions at scale. With a global workforce...

  • Regulatory Affairs Manager

    4 days ago

    Baldwin Park, California, United States Ready Pac Produce, Inc Full time

    Job DescriptionPosition Summary:The Regulatory Compliance Manager is responsible for the development, oversight and implementation of the regulatory standards across the supply chain in support of business objectives. This position effectively collaborates with cross-functional teams to drive regulatory compliance of the products and processes.Key...

  • Senior Audit Specialist

    2 weeks ago

    Menlo Park, California, United States META Full time

    Overview:Meta is on the lookout for a skilled Senior Audit Specialist to enhance our Internal Audit team, focusing on assurance audits within Meta's FinTech (payments) sector. The ideal candidate will possess substantial experience in assessing risks and controls related to payment solutions, machine learning applications, data workflows, and various metrics...

  • Environmental Program Operations Coordinator

    2 weeks ago

    Menlo Park, California, United States CEA Consulting, Inc. Full time

    About CEA Consulting, Inc.CEA Consulting, Inc. is dedicated to empowering innovative thinkers and problem solvers who are committed to fostering sustainable communities and a thriving planet. Our collaborative approach aims to tackle pressing global challenges, from climate change to social inequities, while promoting democratic values. With a strong...

  • Vice President of Technical Operations

    2 weeks ago

    Menlo Park, California, United States Antheia, Inc. Full time

    About Antheia, Inc.: Antheia is a pioneering science and technology firm focused on the development of advanced plant-inspired pharmaceuticals. By leveraging synthetic biology, genomics, bioinformatics, data science, and fermentation techniques, we extract the most advantageous molecules from plants to produce active pharmaceutical ingredients in a more...