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
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
  • serp_jobs.job_card.permanent
job_description.job_card.job_description

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.
    • serp_jobs.job_alerts.create_a_job

    Senior Manager Regulatory • Aliso Viejo, CA, United States

    Job_description.internal_linking.related_jobs
    Senior Regulatory Affairs Manager

    Senior Regulatory Affairs Manager

    VirtualVocations • Garden Grove, California, United States
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Regulatory Affairs Manager (97.25)

    Regulatory Affairs Manager (97.25)

    American States Water • San Dimas, CA, US
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Specialist, Regulatory Affairs

    Senior Specialist, Regulatory Affairs

    Quest Diagnostics • San Juan Capistrano, CA, US
    serp_jobs.job_card.full_time +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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Regulatory Affairs Lead

    Regulatory Affairs Lead

    VirtualVocations • Pasadena, California, United States
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Regulatory Affairs Analyst

    Regulatory Affairs Analyst

    Vaco by Highspring • Tustin, California, United States
    serp_jobs.job_card.temporary
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Manager Regulatory Affairs (Laguna Hills)

    Senior Manager Regulatory Affairs (Laguna Hills)

    Groe Advisors • Laguna Hills, CA, United States
    serp_jobs.job_card.full_time +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 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Senior Manager Regulatory and Quality Affairs (Huntington Beach)

    Senior Manager Regulatory and Quality Affairs (Huntington Beach)

    MedIT • Huntington Beach, CA, United States
    serp_jobs.job_card.full_time
    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 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    AMVAC CHEMICAL CORP • Newport Beach, CA, US
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Regulatory Affairs Specialist, Sr.

    Regulatory Affairs Specialist, Sr.

    Glidewell • Irvine, CA, US
    serp_jobs.job_card.full_time
    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 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Sr. Regulatory Affairs Specialist (Corona del Mar)

    Sr. Regulatory Affairs Specialist (Corona del Mar)

    PRISMATIK DENTALCRAFT, INC. • Corona del Mar, CA, United States
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Senior Director of Regulatory Affairs

    Senior Director of Regulatory Affairs

    VirtualVocations • Fontana, California, United States
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Manager, Regulatory Affairs - Device (Onsite or Remote)

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

    AbbVie • Irvine, CA, US
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Regulatory Affairs Specialist II - Temporary

    Regulatory Affairs Specialist II - Temporary

    Bio-Rad Laboratories • Irvine, CA, United States
    serp_jobs.job_card.full_time
    Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation revisi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Manager / Sr. Manager, Global Regulatory Affairs

    Manager / Sr. Manager, Global Regulatory Affairs

    Arrowhead Pharmaceuticals • Pasadena, CA, US
    serp_jobs.job_card.full_time
    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...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Regulatory Affairs Specialist

    Senior Regulatory Affairs Specialist

    Medtronic Plc • Irvine, CA, US
    serp_jobs.job_card.full_time
    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 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Manager Regulatory Affairs (Lake Forest)

    Senior Manager Regulatory Affairs (Lake Forest)

    Groe Advisors • Lake Forest, CA, United States
    serp_jobs.job_card.full_time +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 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Regulatory Affairs Manager - Electric (90.25)

    Regulatory Affairs Manager - Electric (90.25)

    American States Water • San Dimas, CA, US
    serp_jobs.job_card.full_time
    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 ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Regulatory Information Management Manager

    Regulatory Information Management Manager

    VirtualVocations • Ontario, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Manager, Regulatory Information Management.Key Responsibilities Advise on centralized regulatory business systems operations and monitor data standards Support central...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new