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, Clinical Regulatory Affairs
  • Cymabay Therapeutics
  • Newark, CA FULL_TIME
  • Summary:
    The Director of Regulatory Affairs will support the development and implementation of regulatory strategies for pipeline programs.  The Director will provide strategic and operational leadership in the initiation and maintenance of global clinical trial applications, contribute to the development of regulatory affairs content for US and global regulatory submissions, interactions with FDA and other regulatory agencies worldwide, and the overall global regulatory strategy. The Director will work with functional areas and project teams to support product teams to support product development and approval.  This role requires strong knowledge and interpretation of global rules, regulations, and guidance governing drugs in all phases of development.  This individual must have extensive experience in drug development, developing regulatory strategies, managing regulatory submissions and marketing applications in eCTD format. In addition, this individual must be able to work independently, be highly-collaborative, creative, flexible to different ideas, and remain grounded in a dynamic fast paced environment. Of importance is this individual’s willingness to assist others when called upon to ensure the success of the team and business objectives and strong oral and written communication skills.   The Director of Regulatory Affairs will also recruit, retain, and develop regulatory staff to meet organizational needs.  The Director will be onsite in Newark, CA typically 3 days per week.

    Essential Functions and Job Responsibilities:
    • Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products.
    • Develop global regulatory plans to facilitate the progress of programs in all phases of development.
    • Identify risk mitigation strategies and influence project teams to maximize the likelihood of regulatory success.
    • Support efficient conduct of development programs, while maintaining compliance with ICH requirements, regional requirements, and company procedures.
    • Managing regulatory documents and submissions supporting IND/CTA and marketing applications.
    • In collaboration with cross-functional teams and/or outside consultants obtain timely regulatory deliverables and ensure regulatory compliance.
    • Advise other departments on Health Authority requirements for product development and regulatory submissions.
    • Lead planning and preparation of Regulatory Agency meetings, working closely with SMEs.  Deliverables include core content for briefing documents, presentations, and strategy documents.
    • Expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs.
    • Develop internal regulatory procedures and practices.
    • Complete other responsibilities as assigned and agreed upon.
    Minimum Qualifications:
    • Bachelor’s degree or equivalent work experience in Regulatory Affairs or related discipline required.  Advanced degree (MS, PharmD, or PhD preferred).
    • At least eight years of experience in Regulatory Affairs for pharmaceutical drugs.
    • Proven track record of managing critical projects as part of an interdisciplinary team.
    • Proven track record of representing the department in project teams, committees and external meetings.
    • Prior experience managing regulatory submission to deadlines.
    • Experience with rare/orphan drugs preferred but not required. 
    • Experience interacting with Health Authorities including meeting preparation.
    • Experience managing a team.
    • Knowledgeable in ICH, EMA, and FDA guidelines.  Understanding of GxP systems and Quality principles.
    • Ex-US and/or global regulatory experience highly desired.
    • Ability to research global regulatory guidance (nonclinical and clinical) precedence to assist in the development and execution of global regulatory strategies.
    • Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions.
    • Excellent writing, oral and organizational skills, time management and ability to generate clear, concise documents.
    • Proficiency in using Microsoft Word, Excel and PowerPoint.
    • Continuous quality improvement, and attention to detail.
    • Collaborative, strong team player, self-motivated team player who is comfortable in wearing many hats.
  • 16 Days Ago

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Director Regulatory Affairs *Remote
  • Providence Health
  • California, CA FULL_TIME
  • Description Providence Health Plan caregivers are not simply valued – they’re invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitme...
  • 17 Days Ago

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Associate Director, Regulatory Affairs
  • 4D MOLECULAR THERAPEUTICS
  • Emeryville, CA FULL_TIME
  • At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as ...
  • 18 Days Ago

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Director of Regulatory Affairs
  • Imperative Care Inc
  • Campbell, CA FULL_TIME
  • SUMMARY: Manage day to day activities for Regulatory Affairs function. Partner with internal departments and external consultants to efficiently deliver accurate, timely, and effective regulatory docu...
  • 22 Days Ago

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Director, Regulatory Affairs
  • MML US Inc
  • San Diego, CA FULL_TIME
  • This position is onsite in San Diego.Mainstay MedicalMainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with dis...
  • 9 Days Ago

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Director, Regulatory Affairs
  • Welcome to the Tarsanet Internal Career Center!
  • Irvine, CA FULL_TIME
  • About the Role The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval. The...
  • 10 Days Ago

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Regulatory Affairs Director
  • The Judge Group
  • Boston, MA
  • About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehens...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Atrium Medical
  • Hudson, NH
  • Position Specific Requirements: Responsible for internal, domestic, and international compliance activities working unde...
  • 4/26/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Einride
  • Austin, TX
  • Want to be part of transforming road freight - for good? Einride is showing the world a new way to move, based on the la...
  • 4/24/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Thor Companies
  • Must be able to be on site 3 days per week in the San Francisco Bay Area! Key Responsibilities Provide strategic and ope...
  • 4/24/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Dyne Therapeutics
  • Waltham, MA
  • Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-tran...
  • 4/24/2024 12:00:00 AM

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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...
  • 4/23/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs
  • Accordance Search Group
  • Cambridge, MA
  • What this position is all about: We are looking for a strategic and results-driven Head of Regulatory Affairs (level com...
  • 4/23/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Accordance Search Group
  • Somerville, MA
  • What if you could join a company rapidly advancing its first candidate to clinic and play a critical role in bringing ne...
  • 4/22/2024 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
$186,436 to $265,528

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