Senior Manager, Regulatory Operations

4 weeks ago

Menlo Park, United States Meet Full time

Senior Manager, Regulatory Operations

This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects.


Responsibilities include:

  • Maintaining regulatory records within the Veeva Vault RIM system
  • Managing the change control process in Veeva Vault RIM
  • Ensuring up-to-date US/ex-US submissions and correspondence files within the Regulatory shared drive
  • Collaborating with external publishing vendors for e-submission files and receipts
  • Managing the spreadsheet tracking weekly/monthly regulatory submissions and communicating with external publishing vendors
  • Maintaining templates and style guides for regulatory submissions
  • Providing support to other Regulatory team members and their projects
  • Participating in the development of standard operating procedures


Preferred Skills, Qualifications, and Technical Proficiencies:

  • Preferably experienced with Veeva Vault systems
  • Detail-oriented with excellent oral and written communication skills
  • Strong team player, self-motivated, capable of working independently and collaboratively
  • Ability to manage multiple projects simultaneously in a dynamic environment
  • Proficient in organization, prioritization, and time management
  • Proficiency in Microsoft Word, PowerPoint, and Excel


Preferred Education and Experience:

  • BA/BS degree in a scientific discipline
  • 5+ years’ experience in the pharmaceutical industry or life sciences, with at least 4 years in regulatory affairs



Interested? Apply here and send your CV to susan.clasby@peoplewithchemistry.com

  • Senior Manager, Regulatory Operations

    1 week ago

    Menlo Park, United States Meet Recruitment Full time

    Senior Manager, Regulatory Operations This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects. Responsibilities...

  • Senior Manager, Regulatory Operations

    3 weeks ago

    Menlo Park, United States Meet Full time

    Manager or Senior Manager, Regulatory Operations*Hybrid Workstyle - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Manager or Senior Manager of Regulatory Operations to...

  • Senior Manager, Regulatory Operations

    4 weeks ago

    Menlo Park, United States Meet Full time

    Manager or Senior Manager, Regulatory Operations*Hybrid Workstyle - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Manager or Senior Manager of Regulatory Operations to...

  • Senior Manager, Regulatory Affairs

    3 weeks ago

    Menlo Park, United States Meet Recruitment Full time

    Senior Manager, Regulatory Affairs *Hybrid Role - Menlo Park, CA* Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support...

  • Senior Manager, Regulatory Affairs

    3 weeks ago

    Menlo Park, United States Meet Full time

    Senior Manager, Regulatory Affairs *Hybrid Role - Menlo Park, CA* Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support...

  • Senior Manager, Regulatory Affairs

    3 weeks ago

    Menlo Park, United States Meet Full time

    Senior Manager, Regulatory Affairs*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support their...

  • Senior Manager, Regulatory Affairs

    2 weeks ago

    Menlo Park, United States Meet Full time

    Senior Manager, Regulatory Affairs*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support their...

  • Senior Manager, Regulatory Affairs

    3 weeks ago

    Menlo Park, United States Meet Full time

    Senior Manager, Regulatory Affairs*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support their...

  • Senior Director, Regulatory Affairs, Ad/Promo

    3 weeks ago

    Menlo Park, United States Meet Full time

    Senior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...

  • Senior Director, Regulatory Affairs, Ad/Promo

    3 weeks ago

    Menlo Park, United States Meet Full time

    Senior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...

  • Senior Director, Regulatory Affairs, Ad/Promo

    3 weeks ago

    Menlo Park, United States Meet Full time

    Senior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...

  • Regulatory Operations/Project Management Consultant

    3 weeks ago

    Menlo Park, California, United States ReCode Therapeutics Full time

    Who We Are:ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...

  • Senior Director, Regulatory Affairs, Ad/Promo

    4 days ago

    Menlo Park, CA, United States Meet Full time

    Senior Director, Regulatory Affairs - Advertising and Promotion *Hybrid Role - Menlo Park, CA* Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...

  • Regulatory Operations/Project Management Consultant

    2 weeks ago

    Menlo Park, United States ReCode Therapeutics Full time

    Who We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...

  • Regulatory Operations/Project Management Consultant

    2 weeks ago

    Menlo Park, United States ReCode Therapeutics Full time

    Who We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...

  • Regulatory Operations/Project Management Consultant

    7 hours ago

    Menlo Park, United States ReCode Therapeutics, Inc Full time

    Who We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...

  • Head of Regulatory Affairs and Quality

    1 month ago

    Menlo Park, United States Russell Solutions Group Full time

    Job DescriptionJob DescriptionHead of Regulatory Affairs and QualityAbout This Role:We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of regulatory submissions. The incumbent will drive...

  • Head of Regulatory Affairs and Quality

    1 month ago

    Menlo Park, United States Russell Solutions Group Full time

    Job DescriptionJob DescriptionHead of Regulatory Affairs and QualityAbout This Role:We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of regulatory submissions. The incumbent will drive...

  • Senior Manager, Clinical Supply Chain Planninig

    1 month ago

    Menlo Park, United States Meet Full time

    Senior Manager, Clinical Supply Chain Planning:Location: Menlo Park, CA (Hybrid, 3 days onsite)Responsibilities:As the Senior Manager, Clinical Supply Chain Planning, you will be responsible for overseeing the operational activities related to the management of clinical trial materials. Working closely with cross-functional teams, including Clinical...

  • Senior Manager, Clinical Supply Chain Planninig

    2 months ago

    Menlo Park, United States Meet Full time

    Senior Manager, Clinical Supply Chain Planning:Location: Menlo Park, CA (Hybrid, 3 days onsite)Responsibilities:As the Senior Manager, Clinical Supply Chain Planning, you will be responsible for overseeing the operational activities related to the management of clinical trial materials. Working closely with cross-functional teams, including Clinical...