Current jobs related to Regulatory Affairs Senior Associate - Thousand Oaks CA United States - Randstad Life Sciences US

  • Regulatory Affairs Senior Associate

    3 weeks ago

    Thousand Oaks, California, United States Lifelancer Full time

    We are seeking a highly skilled Regulatory Affairs Senior Associate to join our team at Lifelancer. As a key member of our regulatory affairs department, you will play a critical role in supporting the development and implementation of regulatory strategies.

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Thousand Oaks, United States Lifelancer Full time

    Job Title: Senior Regulatory Affairs Specialist (USA - Remote)Job Location: Thousand Oaks, CA, USAJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelEmployer Industry: Medical Device ManufacturingWhy Consider This Job Opportunity Salary up to $125,100 Potential for annual performance bonus and comprehensive...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Thousand Oaks, United States Lifelancer Full time

    Job Title: Senior Regulatory Affairs Specialist (USA - Remote)Job Location: Thousand Oaks, CA, USAJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelEmployer Industry: Medical Device ManufacturingWhy Consider This Job Opportunity Salary up to $125,100 Potential for annual performance bonus and comprehensive...

  • Regulatory Affairs Professional

    2 weeks ago

    Thousand Oaks, California, United States accordance search group Full time

    Accordance Search Group is seeking a highly skilled Regulatory Affairs Professional to join our team. As a key member of our regulatory affairs department, you will be responsible for providing comprehensive support for new product launches and existing product lines.Your primary duties will include collaborating with cross-functional teams to develop and...

  • Regulatory Affairs Specialist

    1 week ago

    Thousand Oaks, California, United States PSC Biotech Full time

    PSC Biotech is committed to providing exceptional services to the life sciences industry. As a Regulatory Affairs Specialist, you will play a key role in ensuring compliance with industry regulations and quality standards. Your expertise in regulatory affairs, combined with your technical skills, will enable you to thrive in this challenging yet rewarding...

  • Regulatory Affairs Manager

    7 days ago

    Thousand Oaks, California, United States accordance search group Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Specialist to join our team at Accordance Search Group. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with global regulations and guidelines for medical devices.**Key Responsibilities:**Provide comprehensive regulatory support for new...

  • Regulatory Affairs Expert for Medical Device Manufacturing

    2 weeks ago

    Thousand Oaks, California, United States Lifelancer Full time

    Job Opportunity: Senior Regulatory Affairs Specialist in Thousand Oaks, CAWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Thousand Oaks, CA. As a key member of our regulatory affairs department, you will be responsible for planning and coordinating medical device regulatory submissions across various international...

  • Regulatory Affairs Director

    4 weeks ago

    San Francisco, CA, United States Biolink360 Full time

    Company Location: Bay AreaComp: 150K-220KPosition Reports to: VP of Regulatory and Quality Director of Regulatory Affairs - San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop...

  • Senior Director, Regulatory Affairs

    4 weeks ago

    Redwood City, CA, United States Adverum Biotechnologies Full time

    The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be...

  • Regulatory Affairs Senior Associate

    4 weeks ago

    Thousand Oaks, United States Aditi Consulting Full time

    Description: Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support,...

  • Associate Director, CMC Regulatory Affairs

    4 weeks ago

    Emeryville, CA, United States Kyverna Therapeutics Full time

    Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be...

  • Senior Director of Regulatory Affairs

    3 weeks ago

    New York, NY, United States Hobson Prior Full time

    Hobson Prior is seeking a motivated Senior Regulatory Affairs Specialist focused on device development. The successful candidate will ensure regulatory compliance and support the development and commercialization of innovative medical devices. This role requires a strong understanding of regulatory requirements and experience in device development within the...

  • Head of Regulatory Affairs

    3 weeks ago

    Mission, KS, United States Novadip Biosciences Full time

    The Head of Regulatory Affairs is a key member of the Senior Executive Team. As such, he/she provides regulatory strategy to the Chief Executive Officer and takes strategic and operational responsibility for leading global regulatory affairs matters relating to company objectives and programs. As a member of the Senior Executive Team, he/she collaborates in...

  • Senior Director of Regulatory Affairs Advertising

    4 weeks ago

    Boston, MA, United States EPM Scientific - Phaidon International Full time

    Title: Senior Director of Regulatory Affairs Ad/Promo Summary: A global biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Senior Director of Regulatory Affairs Ad/Promo to join their team! The team is growing rapidly as they have had great...

  • Senior Regulatory Affairs Consultant

    4 weeks ago

    Billerica, MA, United States Parexel International Corporation Full time

    If you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E-X-P-A-N-D-I-N-G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight-knit team of...

  • Senior Regulatory Affairs Director, Global Regulatory Strategy

    3 weeks ago

    Boston, MA, United States AstraZeneca Full time

    Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we are using cell therapy to revolutionize the treatment of...

  • Manager, Regulatory Affairs

    3 weeks ago

    Lakewood, CO, United States TERUMO BCT, INC Full time

    Manager, Regulatory Affairs Date: Sep 24, 2024 Location: Lakewood, CO, US Requisition ID:  32768 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related...

  • Director of Regulatory Affairs- Strategy

    3 weeks ago

    Saint Paul, MN, United States Beacon Hill Staffing Group, LLC Full time

    Beacon Hill Staffing Group, LLC - Director of Regulatory Affairs - Strategy Summary of Position The Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. Responsibilities include defining and/or authoring compliant content for new and existing dossiers,...

  • Associate Director of Regulatory Affairs

    4 weeks ago

    Chicago, IL, United States Tempus AI Inc. Full time

    Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...

  • Executive Director/Vice President, Head of Regulatory Affairs

    4 weeks ago

    Campbell, CA, United States Pailin Group Psc Full time

    Our premier client is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs. Reporting to the Chief Medical Officer, this position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. This position offers the opportunity for you to further develop a career in the...

Regulatory Affairs Senior Associate

2 months ago

Thousand Oaks CA United States Randstad Life Sciences US Full time

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.


Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferred

Position type: 1 year contrat (through November 2025); extension possible.


Position Overview: As a Regulatory Affairs Senior Associate, you will manage regulatory document tracking systems, support clinical trial and marketing activities, and assist with regulatory application submissions and communications with health authorities, ensuring compliance with SOPs and regulatory standards. You’ll serve as the primary point of contact for data management between Regulatory, CMC representatives, publishing teams, and vendors. Key responsibilities include managing Protocol Amendment New Investigator (PANI) submissions, updating PI information, and providing training, mentoring, and support to Data Management team members and other functions, including vendors. Additionally, you’ll collaborate closely with external partners and outsourced CROs.


Essential Duties and Responsibilities:

  • In order to support our team's ongoing projects, we are seeking a candidate who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma methodology, process mapping and project management experience.
  • Regulatory affairs knowledge will be considered.
  • Any Regulatory certifications/qualifications will add value.
  • Technical understanding of Regulatory systems will be desirable. Knowledge and interest in SQLs/Databases will also be considered.


Qualifications:

  • Master's degree (MS) degree OR
  • Bachelor's degree (BS) and two (2) years' experience OR
  • Associate's degree (AS) and sic (6) years of experience OR
  • High school diploma / GED and eight (8) years of experience
  • Experience with SharePoint, Excel, Smartsheet, and Veeva Vault.
  • Excellent communication skills and ability to work closely with stakeholders
  • Ability to work independently and handle multiple prioritites