Current jobs related to Global Director of Regulatory Affairs - South San Francisco - Remegen Biosciences, Inc.

  • Executive Director, Regulatory Affairs

    3 minutes ago

    San Diego, United States Regulatory Affairs Professionals Society Full time

    Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...

  • Global Director of Regulatory Affairs

    3 months ago

    South San Francisco, United States Remegen Biosciences, Inc. Full time

    Job DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...

  • Director of Regulatory Affairs

    4 weeks ago

    South San Francisco, United States Trebla Talent Full time

    Role:Director, Regulatory Affairs Bay Area/HybridCompany Description:This precision oncology biotech is advancing next-generation targeted therapies. Having recently emerged from stealth mode with substantial funding, this pre-IPO company is pioneering new frontiers in antibody engineering and its working! Their innovative approach has already earned FDA...

  • Director of Regulatory Affairs

    3 weeks ago

    South San Francisco, United States Trebla Talent Full time

    Role:Director, Regulatory Affairs Bay Area/HybridCompany Description:This precision oncology biotech is advancing next-generation targeted therapies. Having recently emerged from stealth mode with substantial funding, this pre-IPO company is pioneering new frontiers in antibody engineering and its working! Their innovative approach has already earned FDA...

  • Executive Director/ Senior Director, Regulatory Affairs

    4 weeks ago

    South San Francisco, California, United States Annexon, Inc. Full time

    Work LocationCorporate Headquarters (South San Francisco, CA) – HybridPosition SummaryThis role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet...

  • Director of Regulatory Affairs CMC

    2 months ago

    San Francisco, United States SciPro Full time

    Director Regulatory Affairs CMCSan Francisco, CA (Hybrid)6 month initial contract (likely extension and conversion to FTE)This client is a clinical-stage precision oncology biotech focused on creating cutting-edge therapies to target cancer treatments. Responsibilities:Develop and implement CMC regulatory strategies to facilitate the clinical development and...

  • Director, Regulatory Affairs

    1 month ago

    South San Francisco, California, United States tapwage Full time

    About Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...

  • Regulatory Affairs Director

    14 hours ago

    San Francisco, California, United States BridgeBio Pharma Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Director to join our team at BridgeBio Pharma. As a key member of our global regulatory team, you will be responsible for providing strategic regulatory expertise to support the continued development and commercialization of our investigational product, acoramidis.Key ResponsibilitiesDevelop...

  • Head of Regulatory Affairs Strategy

    4 days ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewAlumis Inc. is a pioneering company dedicated to enhancing the lives of individuals affected by autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to fundamentally improve outcomes for these individuals. We are in...

  • Head of Regulatory Affairs Strategy

    3 days ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: $220,000 to $250,000 annuallyAlumis Inc. is a pioneering company in precision medicine, dedicated to enhancing the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to...

  • Head of Regulatory Affairs Strategy

    4 days ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewAlumis Inc is dedicated to revolutionizing the treatment landscape for patients grappling with autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to fundamentally enhance patient outcomes. We are in search of...

  • Head of Regulatory Affairs Strategy

    4 days ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: Alumis Inc is dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to dramatically improve patient outcomes. We are in...

  • Head of Regulatory Affairs Strategy

    1 week ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: $220,000 to $250,000 annuallyAlumis Inc is dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to profoundly alter the...

  • Head of Regulatory Affairs Strategy

    4 days ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewAlumis Inc. is a pioneering company in precision medicine dedicated to improving the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to fundamentally enhance the outcomes for...

  • Lead Global Regulatory Affairs Specialist

    1 week ago

    San Francisco, California, United States Eko Devices Full time

    About Eko Devices: Eko is committed to enhancing the capabilities of healthcare professionals by providing cutting-edge digital solutions for cardiopulmonary assessment. Our innovative platform empowers clinicians to accurately identify and manage cardiopulmonary conditions, ensuring optimal patient care.Company Growth: With substantial backing exceeding...

  • Director of Regulatory Compliance

    18 hours ago

    South San Francisco, California, United States Alumis Full time

    Job SummaryWe are seeking an experienced Regulatory Strategy Director to join our team at Alumis Inc. in South San Francisco, CA. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies to facilitate the progress of assigned programs in all phases of development.Key...

  • Lead Regulatory Affairs Strategist

    1 week ago

    South San Francisco, California, United States Cytokinetics Full time

    Cytokinetics is a pioneering biopharmaceutical organization specializing in the cardiovascular sector, dedicated to the innovation, development, and commercialization of groundbreaking muscle activators and inhibitors aimed at addressing severe conditions where cardiac muscle functionality is impaired. As a frontrunner in muscle biology and performance...

  • Regulatory Strategy Director

    17 hours ago

    South San Francisco, California, United States Alumis Full time

    Job SummaryWe are seeking a highly motivated and experienced Regulatory Strategy Director to join our team at Alumis Inc. in South San Francisco, CA. As a key member of our project teams, you will provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in obtaining worldwide approvals to market our products.Key...

  • Regulatory Affairs Director

    21 hours ago

    San Diego, California, United States Modular Medical Inc Full time

    Job Description**Job Title:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...

  • Director of Regulatory Affairs

    3 weeks ago

    San Carlos, United States HealthCare Recruiters International Full time

    Our client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small...

Global Director of Regulatory Affairs

2 months ago

South San Francisco, United States Remegen Biosciences, Inc. Full time
Job DescriptionJob DescriptionORGANIZATION

RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Biosciences is a wholly owned subsidiary of RemeGen Co., Ltd a global pharmaceutical company specialized in autoimmune, oncology and ophthalmic diseases.

POSITION SUMMARY

The Director of Global Regulatory Affairs will serve as a pivotal member of the organization, overseeing regulatory strategies and operations, particularly for product registrations and indications in international markets, with a focus on the US, EU, Australia, and China. This role will be the local regulatory lead and internal expert for the Autoimmune Clinical Development team, providing regulatory guidance to cross-functional project teams, ensuring compliance with international regulations, assessing regulatory risks, and engaging with health authorities. With a strong scientific and technical background in large molecular drug-development, the Director will strategically manage interactions with regulatory agencies, optimize project submissions, and maintain vigilant awareness of evolving regulatory landscapes. This is a remote position for candidates located in Massachusetts, Pennsylvania, South Carolina, and Texas.

KEY RESPONSIBILITIES
 
  • As local regulatory lead, represent Regulatory Affairs (RA) in assigned project meetings and provide regulatory guidance as appropriate, and for preparation of regulatory documents.
  • Serve as an internal expert in International RA by providing strategic and operational guidance to management and project teams for the international registration of new products or new indications, especially for the US, EU, and Australia, including:
    • Providing interpretation regarding regulations and advice on interactions with agencies (FDA, EU, etc.) and their guidance requirements.
    • Monitor and anticipate changes in regulatory and access environments that might impact company portfolio programs and provide timely advice to management and project teams.
    • Identify and assess regulatory risks, mitigations, and contingencies.
    • Support China product RA lead or indication RA lead to prepare and review meeting requests and briefing documents; responsible for submission and follow up with the review and responses to requests from regulatory agencies.
  • Work with RemeGen China product RA lead or indication RA lead to plan, prepare, and review submissions to regulatory agencies, to support RA submission approval. Ensure all documents and communications with regulatory agencies are timely, accurate, complete, verifiable, and in compliance with agencies’ requirements.
  • Responsible for organizing FDA communication meetings to ensure meeting quality.
  • Responsible for managing CRO depending on project assignment.
  • Responsible for the preparation, review, and submission of ODD documents in the U.S. and Europe.
  • Liaison with health authorities as needed.
  • Archive management for related projects, sending to China’s central archiving.

REQUIREMENTS
 Education:
  • BS in a science related field, required.
  • Advanced training in medical or life sciences is a plus.
Experience:
  • 10+ years of relevant regulatory/industry experience in both biotech or pharmaceuticals.
  • At least 8 years as the Global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
  • Must have experience supporting clinical development teams in the autoimmune space.
  • Scientific, technical, and developmental background in large molecular drug development is highly desired.
  • Experience from IND through to BLA, across all disciplines (nonclinical, clinical, CMC), as well as attending/running regulatory interactions.
Skills:
  • Knowledge and understanding of autoimmune disease biology and translational research is required.
  • Recognize concept of “one registration” and recognize the differences in responsibilities between Headquarters and local teams.
  • Excellent written and verbal communication skills.
  • Ability to work cross-functionally in a fast-paced, collaborative environment.
  • Strong attention to detail and problem-solving skills.

OTHER
 Supervisory Responsibilities:None.
 Equipment To Be Used:Laptop computer, other office equipment, and/or lab equipment.
 Typical Physical Demands:Manual dexterity sufficient to operate standard office equipment.
 Working Conditions:Works remotely. Occasionally called upon to work hours in excess of your normal daily schedule. Travel as needed.
BENEFITS
 Benefits:
  • 401(k) and matching program
  • Medical, Vision, and Dental Insurance
  • Flexible Spending Account
  • Short- and long-term disability
  • Life insurance
  • Employee Assistance Program
  • Employee discounts
  • Paid time off/vacation/sick time
  • Professional development assistance
  • Referral program

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from employer.
 

Powered by JazzHR

Rorcp7Nim7