Regulatory Affairs Director jobs in San Francisco, CA

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Global Director of Regulatory Affairs
  • Remegen Biosciences, Inc.
  • South San Francisco, CA FULL_TIME
  • ORGANIZATION

    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.
  • 1 Month Ago

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Associate Director, Regulatory Affairs
  • Alector
  • South San Francisco, CA FULL_TIME
  • Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our soc...
  • 25 Days Ago

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Senior Director, Regulatory Affairs
  • ALX Oncology Inc.
  • South San Francisco, CA FULL_TIME
  • ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a n...
  • 1 Month Ago

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Director, Regulatory Affairs, Advertising and Promotion
  • Cytokinetics
  • South San Francisco, CA FULL_TIME
  • As the Director of Regulatory Affairs, Advertising and Promotion, you will report directly to the Executive Director, Regulatory Affairs. Your primary responsibility will be to lead commercial regulat...
  • 22 Days Ago

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Associate Director, Regulatory Affairs - AdPromo
  • Bausch Health
  • San Francisco, CA FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 1 Month Ago

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Senior Director, CMC Regulatory Affairs
  • Allogene Therapeutics
  • South San Francisco, CA 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 (All...
  • 1 Month Ago

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0 Regulatory Affairs Director jobs found in San Francisco, CA area

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Director, CMC Regulatory Affairs
  • Bayside Solutions
  • Fremont, CA
  • Director, CMC Regulatory Affairs Direct Hire Fulltime Role Salary Range: $208,000 - $235,000 per year Location: Redwood ...
  • 4/26/2024 12:00:00 AM

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Director of Regulatory Affairs Fluorescence Imaging
  • Intuitive Surgical
  • Sunnyvale, CA
  • Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enha...
  • 4/24/2024 12:00:00 AM

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Associate Director, Regulatory Affairs Advertising and Promotion
  • Gilead Sciences Inc.
  • San Mateo, CA
  • Associate Director, Regulatory Affairs Advertising and Promotion page is loaded Associate Director, Regulatory Affairs A...
  • 4/24/2024 12:00:00 AM

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Sr. Director Regulatory Affairs
  • Life Science People
  • South San Francisco, CA
  • Senior Director of Regulatory Affairs Menlo Park, CA Life Science People are currently working with an exciting client, ...
  • 4/23/2024 12:00:00 AM

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Sr. Director Regulatory Affairs
  • Life Science People
  • South San Francisco, CA
  • Senior Director of Regulatory Affairs Menlo Park, CA Life Science People are currently working with an exciting client, ...
  • 4/23/2024 12:00:00 AM

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Associate Director, Regulatory Affairs, Labeling
  • Gilead Sciences Inc.
  • San Mateo, CA
  • Associate Director, Regulatory Affairs, Labeling page is loaded Associate Director, Regulatory Affairs, Labeling Apply l...
  • 4/23/2024 12:00:00 AM

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Head of Engineering | Next Gen Biosensor/Proteomics Start-Up | Report to Founder/CEO | San Francisco-based | Retained Search
  • Cornerstone Search Group
  • Head of Engineering | Next Gen Biosensor/Proteomics Start-Up | Report to Founder/CEO | San Francisco-based | Retained Se...
  • 4/23/2024 12:00:00 AM

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Senior Director, Materials Science Biologics Technical Development
  • Gilead Sciences Inc.
  • San Mateo, CA
  • Senior Director, Materials Science Biologics Technical Development page is loaded Senior Director, Materials Science Bio...
  • 4/23/2024 12:00:00 AM

San Francisco is located on the West Coast of the United States at the north end of the San Francisco Peninsula and includes significant stretches of the Pacific Ocean and San Francisco Bay within its boundaries. Several picturesque islands—Alcatraz, Treasure Island and the adjacent Yerba Buena Island, and small portions of Alameda Island, Red Rock Island, and Angel Island—are part of the city. Also included are the uninhabited Farallon Islands, 27 miles (43 km) offshore in the Pacific Ocean. The mainland within the city limits roughly forms a "seven-by-seven-mile square", a common local collo...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$211,283 to $300,916
San Francisco, California area prices
were up 4.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020