Talent.com
Senior Manager Regulatory Affairs (Aliso Viejo)
Senior Manager Regulatory Affairs (Aliso Viejo)Groe Advisors • Aliso Viejo, CA, United States
Senior Manager Regulatory Affairs (Aliso Viejo)

Senior Manager Regulatory Affairs (Aliso Viejo)

Groe Advisors • Aliso Viejo, CA, United States
Hace 1 día
Tipo de contrato
  • A tiempo completo
  • Indefinido
Descripción del trabajo

Sr. Manager, Regulatory Affairs

Aliso Viejo, CA

Hybrid work schedule

Full Time / Direct Hire

In this key leadership role, you will drive and support the execution of global regulatory strategies for innovative drug / device combination products and prescription pharmaceuticals. You will lead the preparation of high-quality regulatory submissions, ensure cross-functional alignment, and help shape product development, regulatory approvals, and long-term compliance. Your work will help bring pioneering treatments to patients globally.

At the company, were a community of innovators focused on transforming the standard of care for chronic eye diseases. With a pioneering spirit and patient-first mindset, we are advancing bold new treatments that improve lives. Join our client as they lead the way in sight-saving innovation.

What Will You Do?

Drive Regulatory Strategy and Execution :

  • Lead and implement global regulatory strategies for combination products and pharmaceuticals in alignment with development goals.
  • Provide strategic regulatory input to interdisciplinary teams on development plans, labeling, and compliance documentation.
  • Review and approve internal documents supporting product development and lifecycle activities.
  • Represent Regulatory Affairs in cross-functional meetings and project reviews.
  • Mentor and guide junior regulatory team members.

Prepare and Submit Regulatory Documentation :

  • Oversee the planning, authoring, and coordination of high-quality global submissions (e.g., INDs, CTAs, NDAs, supplements, annual reports).
  • Collaborate with subject matter experts to ensure submissions are technically sound, timely, and fully compliant.
  • Identify and resolve technical and regulatory challenges during submission development.

    • Engage with Global Regulatory Authorities :

  • Support and lead interactions with U.S. FDA, EMA, and other global health authorities.
  • Draft and contribute to briefing packages and manage submission-related communications.

    • Collaborate and Lead Across Projects :

  • Ensure regulatory deliverables are aligned with project timelines and milestones.
  • Champion effective cross-functional coordination and regulatory best practices across departments.

    • Stay Informed and Elevate Best Practices :

  • Stay current on FDA, ICH, and EU regulatory changes and trends impacting combination product and pharmaceutical development.
  • Help refine internal regulatory systems, submission templates, and document standards.
  • Share and implement best practices across the team.

    • How Will You Get Here?

    Education :

  • Bachelors degree in a scientific discipline required.
  • Advanced degree (MS, PharmD, PhD) strongly preferred.

    • Experience :

  • 9+ years of experience in the life sciences industry, including 6+ years in Regulatory Affairs focused on pharmaceuticals and / or combination products.
  • Proven experience preparing, leading, and submitting INDs, NDAs, CTAs, and associated amendments and reports.
  • Prior involvement in regulatory interactions with FDA and / or EMA.

    • Knowledge, Skills, and Competencies :

  • Deep knowledge of 21 CFR, FDA / ICH guidelines, GxPs, and applicable EU regulatory frameworks.
  • Excellent written and verbal communication skills with a collaborative and solutions-oriented mindset.
  • Strong critical thinking, project management, and leadership skills.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with document management systems a plus.
  • Regulatory Affairs Certification (RAC) is beneficial.
    • Crear una alerta de empleo para esta búsqueda

    Senior Manager Regulatory • Aliso Viejo, CA, United States

    Ofertas relacionadas
    Regulatory Affairs Manager (97.25)

    Regulatory Affairs Manager (97.25)

    American States Water • San Dimas, CA, US
    A tiempo completo
    Golden State Water Company is one of the largest investor-owned water utilities in the United States.We deliver quality, reliable water to more than 1 million people in over 80 communities througho...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Specialist, Regulatory Affairs

    Senior Specialist, Regulatory Affairs

    Quest Diagnostics • San Juan Capistrano, CA, US
    A tiempo completo +1
    Provide regulatory guidance in product design, clinical studies, market authorization strategies, labeling, advertising, and product withdrawals and recalls. Provide pre-market and post-market regul...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    US Regulatory Affairs Manager

    US Regulatory Affairs Manager

    VirtualVocations • Orange, California, United States
    A tiempo completo
    A company is looking for a US Regulatory Lead.Key Responsibilities Support the Global Regulatory Team in US Regulatory Activities, including IND development and submission Act as the primary poi...Mostrar más
    Última actualización: hace 3 horas • Oferta promocionada • Nueva oferta
    Senior Regulatory Affairs Manager

    Senior Regulatory Affairs Manager

    VirtualVocations • Moreno Valley, California, United States
    A tiempo completo
    A company is looking for a Sr Manager, Regulatory Affairs.Key Responsibilities Prepare and submit moderately complex regulatory submissions and documents for investigational and commercial produc...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Senior Director of Regulatory Affairs

    Senior Director of Regulatory Affairs

    VirtualVocations • Norwalk, California, United States
    A tiempo completo
    A company is looking for a Senior Director, Regulatory Affairs.Key Responsibilities Represent regulatory on cross-functional teams and provide leadership for regulatory deliverables Lead plannin...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Manager Regulatory Affairs (Laguna Hills)

    Senior Manager Regulatory Affairs (Laguna Hills)

    Groe Advisors • Laguna Hills, CA, United States
    A tiempo completo +1
    In this key leadership role, you will drive and support the execution of global regulatory strategies for innovative drug / device combination products and prescription pharmaceuticals.You will lead ...Mostrar más
    Última actualización: hace 1 día • Oferta promocionada
    Senior Manager Global Regulatory Affairs

    Senior Manager Global Regulatory Affairs

    EPM Scientific • Pasadena, CA, US
    A tiempo completo
    A clinical stage biotech organization is seeking a.Manager / Senior Manager Regulatory Affairs.This company is pioneering RNA interference-based therapeutics to address serious diseases with high unm...Mostrar más
    Última actualización: hace 3 días • Oferta promocionada
    Senior Manager Regulatory and Quality Affairs (Huntington Beach)

    Senior Manager Regulatory and Quality Affairs (Huntington Beach)

    MedIT • Huntington Beach, CA, United States
    A tiempo completo
    Medit is a global leader in 3D dental imaging and digital dentistry, with a $2B valuation and customers in over 100 countries. Our industry-leading intraoral scanners and open-platform software are ...Mostrar más
    Última actualización: hace 1 día • Oferta promocionada
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    AMVAC CHEMICAL CORP • Newport Beach, CA, US
    A tiempo completo
    AMVAC, an American Vanguard company, has an opportunity for a.This is an interesting and exciting opportunity to use your expertise to promote and manage AMVAC’s products through their regula...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Regulatory Affairs Specialist, Sr.

    Regulatory Affairs Specialist, Sr.

    Glidewell • Irvine, CA, US
    A tiempo completo
    Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.Maintains company registrations and device listings in the US, Canada, and the EU.Analyzes ...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Sr. Regulatory Affairs Specialist (Corona del Mar)

    Sr. Regulatory Affairs Specialist (Corona del Mar)

    PRISMATIK DENTALCRAFT, INC. • Corona del Mar, CA, United States
    A tiempo completo
    Prismatik Dentalcraft is a division of Glidewell Dental.Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and...Mostrar más
    Última actualización: hace 1 día • Oferta promocionada
    Senior Manager, Regulatory Affairs - Device (Onsite or Remote)

    Senior Manager, Regulatory Affairs - Device (Onsite or Remote)

    AbbVie • Irvine, CA, US
    Teletrabajo
    A tiempo completo
    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable i...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Regulatory Affairs Lead

    Regulatory Affairs Lead

    VirtualVocations • Garden Grove, California, United States
    A tiempo completo
    A company is looking for a Regulatory Affairs Lead, IND / IDE.Key Responsibilities Advise on regulatory pathways, product classification, and study design considerations Lead FDA engagement and ma...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Manager / Sr. Manager, Global Regulatory Affairs

    Manager / Sr. Manager, Global Regulatory Affairs

    Arrowhead Pharmaceuticals • Pasadena, CA, US
    A tiempo completo
    Arrowhead Pharmaceuticals, Inc.Nasdaq : ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them.Using a bro...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Regulatory Affairs Specialist

    Senior Regulatory Affairs Specialist

    Medtronic Plc • Irvine, CA, US
    A tiempo completo
    Senior Regulatory Affairs Specialist - Neurovascular.At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll ...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Manager Regulatory Affairs (Lake Forest)

    Senior Manager Regulatory Affairs (Lake Forest)

    Groe Advisors • Lake Forest, CA, United States
    A tiempo completo +1
    In this key leadership role, you will drive and support the execution of global regulatory strategies for innovative drug / device combination products and prescription pharmaceuticals.You will lead ...Mostrar más
    Última actualización: hace 1 día • Oferta promocionada
    Regulatory Affairs Manager - Electric (90.25)

    Regulatory Affairs Manager - Electric (90.25)

    American States Water • San Dimas, CA, US
    A tiempo completo
    Regulatory Affairs Manager - Electric.Golden State Water Company is one of the largest investor-owned water utilities in the United States. We deliver quality, reliable water to more than 1 million ...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Regulatory Affairs Analyst

    Regulatory Affairs Analyst

    Vaco by Highspring • East Pasadena, California, United States
    Temporal
    Regulatory Affairs Analyst – CPG Industry.Location : El Segundo, CA, Hybrid schedule .Type : Temporary (with potential to extend or convert long-term). A leading and rapidly growing CPG brand in the w...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada