Regulatory Affairs Manager jobs in Pasadena, CA

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established 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 Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Regulatory Affairs manager
  • Kindeva Drug Delivery Careers
  • Los Angeles, CA FULL_TIME
  • Kindeva Drug Delivery

    Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
    ROLE SUMMARY
    Seeking a Regulatory Affairs Manager to support the Kindeva business in maintaining regulatory compliance of existing manufactured products for customers on a global basis by:
    • Managing regulatory compliance activities for Kindeva and existing customer products and registrations as required and providing strategic planning for regulatory changes.
    • Acting as the regulatory lead for site-specific activities (e.g., Quality Reviews, Change Committees, etc.)
    • Co-ordinating and preparing regulatory documentation for clinical trial applications, Drug Master Files (DMFs), medical device technical documentation and registration CTD documents (where required).
    • Managing or mentoring more junior staff as required to achieve the business and role goals and objectives.
    ROLE RESPONSIBILITIES

    Management and Mentoring (Approx. 10-20% of time):
    • Providing input and direction to the site and wider Kindeva business on regulatory matters.
    • Providing regulatory support to team members as required on specific project issues ensuring alignment with global guidelines and legislation and the specific business needs of Kindeva
    • Managing and/or mentoring members of the regulatory team as required.
    Marketed Product and Manufacturing Site Support Duties and Responsibilities (Approx. 60 – 80% of Time):
    • Advising internal and external stakeholders of the likely regulatory requirements associated with planned and unplanned changes made within the site and broader Kindeva organization.
    • Participating in technical reviews of data within technical teams to ensure alignment with current global guidelines and to ensure data is generated to meet regulatory needs, responding to regulatory questions from wider technical teams.
    • Managing regulatory authority meetings as required including preparing briefing documentation and presentations.
    • Membership of project teams, including estimating regulatory resource needs for incorporation into project plans and monitoring of regulatory activities versus the project plan; reporting of issues / delays to management.
    • Attending customer focused meetings and interfacing with identified regulatory contacts at the customer company including preparing and reviewing presentations.
    • Communication of regulatory learnings from other projects. E.g., IND feedback, MAA project feedback, Pre IND meeting outcomes to ensure continuous improvement.
    • Advising on CMC elements of variation / supplement packages as required.
    • Communicating expectations of approval timelines within the organization.
    Other Duties and Responsibilities (Approx. 10-20% of Time):
    • Providing regulatory leadership for site-specific activities
    • Monitoring the developing and evolving global regulatory guidelines which impact the development and maintenance of medicinal products and providing assessments of the implications of the proposed legislation.
    • Recruiting, training, mentoring, motivating, and developing the team. Coaching and encouraging staff to be self-sufficient, to work actively with other departments and to become expert in their fields and where appropriate, to be active key members of project teams.
    • Ensuring continued personal development, identifying gaps, learning through doing and maintaining current knowledge of requirements for the role.
    (Note: Percentages of time spent on job duties are estimates and may vary for each individual depending on experience and knowledge and current business requirements)
    BASIC QUALIFICATIONS

    Education:
    • Graduate in pharmacy or a life science (or equivalent).
    • Additional regulatory qualifications advantageous.
    Experience:
    • 7 years relevant experience of US, European or Global registration procedures (or significant experience in other areas of the pharmaceutical industry).
    Knowledge:
    • In-depth knowledge of the Global Regulatory Affairs environment – Guidelines and legislation.
    • Deep practical knowledge of the drug regulatory processes in the US and background understanding of regulatory processes in other regions.
    • General understanding of drug development and pharmaceutical manufacturing from concept to launch including requirements for product development, manufacturing and marketing and the impact of regulatory changes on business goals/objectives. · Broad understanding of the pharmaceutical business in general and of other relevant associated regulatory areas (e.g., Clinical Affairs, Medical Devices, Chemicals Regulations, etc.).
    Key Capabilities:
    • Able to communicate effectively orally and in writing.
    • Able to work both as part of a cross-functional team but also act independently. · Enthusiastic and determined to achieve set objectives.
    • Comfortable working with detailed technical information but also able to see the overall picture.
    • Possess strong computer skills and excellent organizational capabilities.
    • Demonstrate flexibility, strategic thinking and drive to succeed.
    • Be able to deliver results accurately within demanding time frames.
    • Able to handle a crisis in a professional and positive manner.
    • Able to communicate effectively with colleagues at all levels.
    California residents should review our Notice for California Employees and Applicants before applying.

    Covid-19:
    Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.

    Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.

    Equal Opportunity Employer:
    Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
  • 30 Days Ago

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Principal Regulatory Affairs Specialist
  • Medtronic
  • Northridge, CA FULL_TIME
  • Careers that Change Lives Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and e...
  • Just Posted

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Prin Regulatory Affairs Spec
  • Medtronic
  • Northridge, CA FULL_TIME
  • Careers that Change Lives Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and e...
  • 4 Days Ago

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Regulatory Affairs Specialist II
  • STAAR Surgical
  • Monrovia, CA FULL_TIME
  • MAIN JOB RESPONSIBILITIES / COMPETENCIES1. Plan, prepare and review all aspects of ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and internation...
  • 5 Days Ago

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Vice President, Regulatory Affairs
  • Voxelcloud
  • Los Angeles, CA FULL_TIME
  • Company DescriptionFounded in 2016, VoxelCloud, Inc. is a Los Angeles-based worldwide leader in AI analysis of medical images and video. VoxelCloud’s offerings help healthcare providers make better/ea...
  • 10 Days Ago

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Regulatory Affairs Professional (CMC)
  • Dechra Pharmaceuticals PLC
  • Pomona, CA FULL_TIME
  • Job Introduction Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment,...
  • 13 Days Ago

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0 Regulatory Affairs Manager jobs found in Pasadena, CA area

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Regulatory & Compliance HC Specialist 5 - Irvine Risk Management - F/T Days - 67126-1A
  • Uc Irvine Health
  • Los Angeles, CA
  • Regulatory & Compliance HC Specialist 5 - Irvine Risk Management - F/T Days - 67126-1A Updated: Apr 12, 2024Location: Or...
  • 4/28/2024 12:00:00 AM

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Regulatory & Compliance HC Specialist 5 - Irvine Risk Management - F/T Days
  • University Of California - Irvine Health
  • Orange, CA
  • Updated: Apr 12, 2024Location: OrangeJob Type:Department: Risk ManagementUC Title: REGL AND CMPLNC HC SPEC 5Position Num...
  • 4/28/2024 12:00:00 AM

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Senior Regulatory Coordinator Clinical Research
  • Oncology Institute Inc.
  • Cerritos, CA
  • Senior Regulatory CoordinatorResponsibilities:Serve as the Regulatory Manager in the absence of the acting managerMainta...
  • 4/28/2024 12:00:00 AM

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Senior Regulatory Coordinator
  • UCLA Health
  • Los Angeles, CA
  • General Information Press space or enter keys to toggle section visibility Work Location: Los Angeles, USA Onsite or Rem...
  • 4/27/2024 12:00:00 AM

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Sr. Payroll Compliance Manager
  • Suna Solutions
  • Cerritos, CA
  • Job Title: Payroll Compliance Sr Mgr/Director Pay Rate: $110K to $125K Duration: Full Time Location: Cerritos, CA 90703 ...
  • 4/27/2024 12:00:00 AM

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Executive Chef
  • COREcruitment Ltd
  • Santa Clarita, CA
  • Executive Chef - (Golf Club) Salary: $95,000 - $115,000 Location: Santa Clarita, CA I am thrilled to announce my collabo...
  • 4/26/2024 12:00:00 AM

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Executive Chef
  • Corecruitment Ltd
  • Santa Clarita, CA
  • Executive Chef - (Golf Club) Salary: $95,000 - $115,000 Location: Santa Clarita, CA I am thrilled to announce my collabo...
  • 4/26/2024 12:00:00 AM

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Sr. Payroll Compliance Manager
  • Suna Solutions
  • Cerritos, CA
  • Job Title: Payroll Compliance Sr Mgr/Director Pay Rate: $110K to $125K Duration: Full Time Location: Cerritos, CA 90703 ...
  • 4/26/2024 12:00:00 AM

Pasadena is a city in Los Angeles County, California, United States, located 10 miles (16 kilometers) northeast of Downtown Los Angeles. The estimated population of Pasadena was 142,647 in 2017, making it the 183rd-largest city in the United States. Pasadena is the ninth-largest city in Los Angeles County. Pasadena was incorporated on June 19, 1886, becoming one of the first cities to be incorporated in what is now Los Angeles County, following the city of Los Angeles (April 4, 1850). It is one of the primary cultural centers of the San Gabriel Valley. The city is known for hosting the annua...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$153,464 to $216,469
Pasadena, California area prices
were up 3.2% from a year ago

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Regulatory Affairs Manager in Pierre, SD
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