Talent.com
Regulatory Affairs Manager
Regulatory Affairs ManagerGandiva Insights • San Jose, California, USA
[error_messages.no_longer_accepting]
Regulatory Affairs Manager

Regulatory Affairs Manager

Gandiva Insights • San Jose, California, USA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Title : Regulatory Affairs Manager

Remote

USC or GC

Description :

  • The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a programs lifecycle.
  • The Manager leads the execution of delegated activities including preparation for HA interactions and the preparation of regulatory submissions in support of the strategy.

KEY RESPONSIBILITIES :

  • The RNC Manager responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical / Clinical Lead and may include the following :

    • Development Stage Product

  • Support the development of the nonclinical / clinical regulatory strategy and plan.
  • Assist with selected planning document development and meeting execution activities in preparation for HA meetings / interactions.
  • Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead.
  • Collaborate with CROs that are contracted to perform regulatory submissions / HA interactions for global clinical trials.
  • With oversight by RNC lead develop and coordinate the core nonclinical / clinical content of regulatory submissions.
  • Responsible for ensuring high quality nonclinical / clinical content that adheres to regulations and guidances.
  • Lead the maintenance of IND / CTAs throughout the life of the studies (e.g. annual reports)
  • Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols Annual Reports Briefing Books etc.) and completing regulatory documents / forms for internal review.
  • Collaborate with Reg PM to create and align submission timelines
  • Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.
  • Oversee the collaboration of Nonclin / clin with Reg Ops to provide final documents and QC published outputs for submissions to HA.
  • Organize and maintain the administrative nonclinical and clinical portions of INDs NDAs and BLAs.
  • Oversee the archiving of HA submissions and correspondence
  • Commercial Stage Product
  • Lead the development of updates to the clinical and nonclinical sections of the core dossier used for INTL marketing applications.
  • Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions examples are : clinical or nonclinical supplements to approved US product dossiers and any required annual reports license renewals supplemental filings.
  • Coordinate necessary interactions with INTL in support of INTL MA filings. Examples include : meetings to provide RNC guidance / input on agency interaction submissions RTQs.

    • General

  • Attend relevant functional area and project team meetings.
  • Review understand and stay up to date on regulations guidelines relevant to responsibilities
  • Review documents (SOPs protocols and reports) related to Clinical or Nonclinical studies as necessary
  • Ensure that the PM timelines and tracker accurately reflect submission plans

    • EDUCATION AND EXPERIENCE

    Degree in health or life sciences including chemistry molecular biology or similar. PhD preferred Masters / Bachelors acceptable with relevant experience

    Nonclinical / Clinical Regulatory Affairs experience preferred

    Key Skills

    Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

    [job_alerts.create_a_job]

    Regulatory Manager • San Jose, California, USA

    [internal_linking.similar_jobs]
    Global Regulatory Strategy Chief

    Global Regulatory Strategy Chief

    TikTok • San Jose, CA, United States
    [job_card.full_time]
    A leading social media platform is seeking a Regulatory Counsel to develop and manage its global regulatory legal strategy. The ideal candidate will have a Juris Doctor degree and deep knowledge in ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Regulatory Compliance Manager

    Regulatory Compliance Manager

    National Beverage • Hayward, CA, United States
    [job_card.full_time]
    POSITION OVERVIEW : The Corporate Regulatory Compliance Manager ensures the Company's products comply with all regulatory requirements associated with ingredients, packaging, and labeling.This incl...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr Manager / Associate Director Regulatory Affairs - US Lead

    Sr Manager / Associate Director Regulatory Affairs - US Lead

    NWRPros • Palo Alto, CA, United States
    [job_card.full_time]
    Our Client is a biopharmaceutical company based in the San Francisco Bay Area.The company specializes in antibody discovery and engineering, advancing innovative therapies designed to treat cancer....[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director of Biocompatibility & Regulatory Strategy

    Director of Biocompatibility & Regulatory Strategy

    Abbott Laboratories • Santa Clara, CA, United States
    [job_card.full_time]
    A leading healthcare company is seeking a Director of Biocompatibility to oversee biocompatibility evaluations and ensure regulatory compliance for medical devices. The ideal candidate will have at ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Regulatory Counsel

    Regulatory Counsel

    Waymo • Mountain View, CA, United States
    [job_card.full_time]
    Waymo is an autonomous driving technology company with the mission to be the world's most trusted driver.Since its start as the Google Self-Driving Car Project in 2009, Waymo has focused on buildin...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Quality Assurance and Regulatory Affairs

    Director, Quality Assurance and Regulatory Affairs

    Noah Medical • San Jose, CA, US
    [job_card.full_time]
    Director, Quality Assurance and Regulatory Affairs.Noah Medical is building the future of medical robotics.Our next generation robotic platform targets early diagnosis and treatment of patients acr...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Head of Regulatory Affairs

    Head of Regulatory Affairs

    Health GPT Inc • Palo Alto, CA, United States
    [job_card.full_time]
    About Us Hippocratic AI has developed a safety-focused Large Language Model (LLM) for healthcare.The company believes that a safe LLM can dramatically improve healthcare accessibility and health o...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Head of Regulatory Affairs

    Head of Regulatory Affairs

    Hippocratic AI • Palo Alto, CA, United States
    [job_card.full_time]
    Hippocratic AI has developed a safety-focused Large Language Model (LLM) for healthcare.The company believes that a safe LLM can dramatically improve healthcare accessibility and health outcomes in...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director Regulatory & Clinical Affairs

    Director Regulatory & Clinical Affairs

    Metric Bio • San Jose, CA, United States
    [job_card.full_time]
    Develop and execute regulatory strategies for digital pathology products, imaging devices, and AI / ML-based medical software. FDA submissions including 510(k), De Novo, PMA, Q-Sub meetings, responses...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Director, Titling & Regulatory Operations - US

    Director, Titling & Regulatory Operations - US

    Solera • San Jose, California, United States
    [job_card.full_time]
    A leading technology firm is seeking a Director for their Titling division in San Jose, California.This pivotal role focuses on operational and financial performance, regulatory compliance, and com...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Global Competition & Regulatory Counsel

    Senior Global Competition & Regulatory Counsel

    Apple Inc. • Cupertino, CA, United States
    [job_card.full_time]
    A leading tech company in Cupertino is seeking a qualified individual for the Competition and Regulatory group.This role involves advising on complex legal issues, driving strategy on regulatory ma...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Rehabilitation Physical Therapist

    Travel Rehabilitation Physical Therapist

    Coast Medical Service • Capitola, CA, US
    [job_card.full_time]
    Coast Medical Service is seeking a travel Physical Therapist for a travel job in Capitola, California.Job Description & Requirements. Coast Medical Service is a nationwide travel nursing & a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Affairs Manager Heart Failure (on-site)

    Regulatory Affairs Manager Heart Failure (on-site)

    Abbott • Pleasanton, CA, US
    [job_card.full_time]
    We are seeking a Regulatory Affairs Manager to join Abbott's Heart Failure Division on-site in Pleasanton, CA.As an individual contributor, the function of a Regulatory Affairs Manager is to combin...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Consulting Director, Regulatory Analyst (Utilities / Power / Renewables)

    Consulting Director, Regulatory Analyst (Utilities / Power / Renewables)

    ERM • San Jose, CA, United States
    [job_card.full_time]
    Consulting Director, Planner Regulatory Specialist.ERM has an opportunity for an experienced biologist / regulatory specialist to join our thriving global consulting firm as a.Consulting Director, Pl...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Travel Rehabilitation Physical Therapist

    Travel Rehabilitation Physical Therapist

    Host Healthcare • Capitola, CA, US
    [job_card.full_time]
    Host Healthcare is seeking a travel Physical Therapist for a travel job in Capitola, California.Job Description & Requirements. Pay package is based on 8 hour shifts and 30 hours per week (subje...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Rehabilitation Physical Therapist

    Travel Rehabilitation Physical Therapist

    Uniti Med • Capitola, CA, US
    [job_card.full_time]
    Uniti Med is seeking a travel Physical Therapist for a travel job in Capitola, California.Job Description & Requirements. Cigna medical, MetLife dental and vision insurance .License reimbur...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Affairs Specialist - Regional

    Regulatory Affairs Specialist - Regional

    Cooper Cos. • San Ramon, CA, US
    [job_card.full_time]
    At CooperVision, a division of CooperCompanies, we're driven by a unifying purpose to help people to experience life's beautiful moments. We are connected through our shared values - dedicated, inno...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    Stryker • San Jose, CA, US
    [job_card.full_time]
    Senior Director, Regulatory Affairs.The Senior Director, Regulatory Affairs is a key strategist, responsible for developing regulatory strategy for the Endoscopy business unit and delivering Stryke...[show_more]
    [last_updated.last_updated_30] • [promoted]