Regulatory Affairs Senior Associate

2 weeks 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

  • Regulatory Affairs Senior Associate

    2 weeks ago

    Thousand Oaks, 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 preferredPosition type: 1 year contrat (through November 2025); extension...

  • Regulatory Affairs Senior Associate

    1 week ago

    Thousand Oaks, 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 preferredPosition type: 1 year contrat (through November 2025); extension...

  • Regulatory Affairs Senior Associate

    2 weeks ago

    thousand oaks, 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 preferredPosition type: 1 year contrat (through November 2025); extension...

  • Regulatory Affairs Associate

    2 weeks ago

    Fremont, CA, United States Meet Full time

    Regulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and...

  • Regulatory Affairs Specialist

    4 weeks ago

    Thousand Oaks, California, United States Accordance Search Group Full time

    Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Accordance Search Group. As a key member of our regulatory team, you will be responsible for providing comprehensive regulatory support for new product launches and existing product lines.Key Responsibilities:Develop and implement global regulatory strategies for...

  • Regulatory Affairs Director

    3 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    About the RoleAmgen is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of strategy for the CMC and Device Regulatory Affairs team. This role will ensure strategic alignment across programs and geographies, representing the CMC and Device Regulatory Affairs team with Amgen leadership, governance bodies, regulatory...

  • Regulatory Affairs Director

    3 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Job SummaryAmgen is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of strategy for the CMC and Device Regulatory Affairs team. This role will oversee the development of regulatory strategies, decisions, and implementation plans for the Obesity portfolio.Key ResponsibilitiesDevelop and execute regulatory strategies...

  • Regulatory Affairs Specialist

    4 weeks ago

    Thousand Oaks, California, United States Accordance Search Group Full time

    Job Title: Regulatory SpecialistJob Summary:We are seeking a highly skilled Regulatory Specialist to join our team at Accordance Search Group. The successful candidate will provide comprehensive regulatory support for new product launches and existing product lines, collaborating with cross-functional teams to ensure compliance with regulatory...

  • Senior Regulatory Affairs Specialist

    3 months ago

    Green Oaks, United States Abbott Full time

    The Opportunity Our location in Irving, TX or Abbott Park, IL currently has an opportunity for a Senior Regulatory Affairs Specialist. What You’ll Work On Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Supports necessary regulatory activities required for...

  • Regulatory Affairs Associate

    2 weeks ago

    Irvine, CA, United States US Tech Solutions Full time

    Top 3-5 skills, experience or education required1. Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.3. Detail-oriented with the ability to proofread and check documents for accuracy and consistency.Purpose Statement:The Regulatory Affairs Specialist supports the development...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Green Oaks, United States Abbott Full time

    The Opportunity This position works out of our Lake Bluff, IL (Abbott Park) location in the Transfusion Medicine Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Brea, CA, United States Kelly Science, Engineering, Technology & Telecom Full time

    Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

  • Senior Regulatory Affairs Specialist

    2 months ago

    Green Oaks, United States Abbott Full time

    The Opportunity This position works out of our Lake Bluff, IL (Abbott Park) location in the Transfusion Medicine Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision...

  • Regulatory Affairs Specialist

    3 weeks ago

    Green Oaks, Illinois, United States Abbott Full time

    The OpportunityAt Abbott, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Irving, TX or Abbott Park, IL.What You'll Work OnParticipate as the regulatory functional product team member for the organization's Transfusion Medicine regulatory team.Support necessary regulatory activities required for product market entry...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Irvine, CA, United States NeuroVasc Technologies, Inc. Full time

    We are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This On-site role reports directly to the CEO. The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory...

  • Senior Regulatory Affairs Lead

    2 weeks ago

    Orlando, FL, United States Lorven Technologies Inc. Full time

    Role: Senior Regulatory Affairs Lead, Location: Orlando, FLAdvise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending country guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives and project strategy.Create detailed written regulatory plans that can be...

  • Regulatory Affairs Director Global CMC

    3 weeks ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    Job SummaryAs a member of the BioSpace, Inc. team, you will play a key role in shaping the company's regulatory strategy and ensuring compliance with global regulations. The ideal candidate will have a strong background in CMC regulatory affairs and experience in leading cross-functional teams.Key ResponsibilitiesDevelop and execute CMC regulatory strategies...

  • Senior Associate, Regulatory Affairs

    4 weeks ago

    Hawthorne, CA, United States Sun Pharmaceutical Industries, Inc. Full time

    Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

  • Senior Director, Regulatory Risk Services

    3 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Job Title: Senior Director, Regulatory Risk ServicesAmgen is seeking a highly skilled Senior Director, Regulatory Risk Services to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Develop and implement regulatory strategies...

  • Senior Director of Regulatory Affairs

    1 month ago

    New York, NY, United States MetroPlusHealth Full time

    Empower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest...