Regulatory Affairs Director jobs in California

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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Director, Regulatory Affairs
  • BioSpace
  • South San Francisco, CA FULL_TIME
  • The Position

    Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will collaborate with cross-functional teams, providing your expertise to support the development, review, and approval of strategies and documents crucial for clinical trials and marketing authorizations. Reporting to the Vice President of Regulatory and Quality Science, you'll be at the forefront of regulatory success, working closely with internal and external stakeholders to ensure our projects meet regulatory standards and milestones. If you're ready to make an impact, we want to hear from you!

    Your Impact

    • Provide regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, vendors and consultants to identify optimal and effective regulatory strategies for assigned projects
    • Develop and implement regulatory strategies for clinical development programs in alignment with corporate objectives and regulatory requirements
    • Offer regulatory considerations for the design, conduct, and interpretation of clinical trials
    • Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks
    • Stay informed of emerging regulatory trends, guidance documents, and best practices related to clinical development and regulatory affairs
    • Prepare and lead teams through successful regulatory meetings and interactions
    • Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals
    • Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence
    • Contribute to the development and maintenance of Regulatory Affairs Department working practices and procedures


    As a Director, we also expect our leaders to demonstrate the following Leadership Competencies:

    • Communication and Influence
      • Builds communication channels across Maze for sharing information
      • Influences Senior Management decisions through persuasive arguments
      • Respectfully addresses differing opinions leading to support of decision
    • Teamwork and Collaboration
      • Champions partnerships and connections across Maze
      • Proactively addresses issues that could result in breakdown of team relationships
      • Spotlights team and individual contributions in public forums
    • Execution and Results
      • Addresses gaps and leverages strengths to get best results
      • Maintains a steadying presence and clarifies priorities during change
      • Anticipates and removes barriers that put functional/corporate goals at risk
    • Develop Others and Self
      • Removes barriers to staff development and empowers them to make their own decisions
      • Stays current on industry trends and keeps direct-reports prepared and responsive
    Qualifications

    • Bachelor's degree required. Advanced degree in life sciences preferred.
    • 10 years or equivalent relevant experience in regulatory affairs
    • Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs
    • Experience and expertise in the preparation of IND/CTAs (required) and NDA/BLA/MAAs (desirable), as well as supportive amendments and supplements
    • Proven ability to manage multiple projects, proactively identifying potential problems and to partner effectively and positively to solve issues
    • Excellent organizational and communication skills, both written and verbal
    • Well-prepared, proactive, and comfortable handling broad responsibilities in a fast-paced, small company environment


    About Maze Therapeutics

    Maze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients, with a focus on genetically informed therapies for common diseases, such as chronic kidney disease, and seeks to focus expertise and resources towards underserved communities. Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines. Maze has developed the Maze Compass Platform™, a proprietary, purpose-built platform to understand and integrate the critical step of variant functionalization into each stage of drug development. Utilizing the Maze Compass Platform™, Maze is building a broad portfolio of wholly owned and partnered programs. Its two lead programs are focused in Chronic Kidney Disease (CKD), a condition that impacts an estimated 37m individuals. The first program in CKD addresses a genetic subset of the common disease that has a disproportionate impact on the Black Community. Maze is based in South San Francisco.

    Our People

    Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.

    Our Core Values

    Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.

    Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

    Stand True – Our integrity is foundational; it guides us no matter the obstacle.

    The expected annual salary range for employees located in the San Francisco Bay Area is $218,00 to 267,000. Additionally, this position is eligible for an annual performance bonus.

    Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

    Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.
  • 2 Days Ago

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Director Quality Regulatory Affairs
  • Insight Global
  • Pleasanton, CA CONTRACTOR
  • Duration: 6 month contract to permanent hireLocation: Pleasanton, CA - 4 days a week on-siteInsight Global's Healthcare Client's Clinical Trials Program (CTP) is a regional organization that conducts ...
  • 4 Days Ago

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Director of Regulatory Affairs
  • SpyGlass Pharma, Inc.
  • Aliso Viejo, CA FULL_TIME
  • About SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in glob...
  • 6 Days 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...
  • 9 Days Ago

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Director of Government and Regulatory Affairs
  • esVolta, LP
  • Newport, CA FULL_TIME
  • Company OverviewesVolta, LP is a leading developer, owner, and operator of utility-scale energy storage projects across North America. We are at the forefront of the fast-growing battery energy storag...
  • 9 Days Ago

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Associate Director, Regulatory Affairs
  • Allergan Aesthetics
  • Irvine, CA FULL_TIME
  • Job DescriptionResponsible for the development and implementation of US and Canada regulatory strategic and tactical planning for assigned on market products or those products in development for Aesth...
  • Just Posted

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/11/2024 12:00:00 AM

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Head of Regulatory Affairs
  • EPM Scientific
  • Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
  • 6/10/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/10/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 6/8/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
  • 6/8/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/7/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/7/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Chicago, IL
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/7/2024 12:00:00 AM

California is a state in the Pacific Region of the United States. With 39.6 million residents, California is the most populous U.S. state and the third-largest by area. The state capital is Sacramento. The Greater Los Angeles Area and the San Francisco Bay Area are the nation's second and fifth most populous urban regions, with 18.7 million and 9.7 million residents respectively. Los Angeles is California's most populous city, and the country's second most populous, after New York City. California also has the nation's most populous county, Los Angeles County, and its largest county by area, S...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$187,396 to $266,900

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019