Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Affairs Leader: Strategy & Submissions

Groe Advisors

A leading recruitment firm is seeking a Sr. Manager, Regulatory Affairs to drive regulatory strategies for innovative drug/device products. This mid-senior level role requires expertise in preparing global submissions and engaging with regulatory authorities. Ideal candidates have a strong background in life sciences and at least 6 years in Regulatory Affairs. Benefits include medical insurance and 401(k). #J-18808-Ljbffr

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Leader: Strategy & Submissions in Aliso Viejo, CA vacancy
  •  ...X and  YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development...  ...the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements... 
    Senior
    Full time
    Local area

    AbbVie

    Irvine, CA
    15 days ago
  •  ...Glidewell Dental is seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory compliance and drive high-impact submissions. You’ll lead FDA 510(k)/PMA filings, maintain international registrations, and partner with technical teams to ensure... 
    Senior

    Glidewell Dental

    Irvine, CA
    3 days ago
  •  ...in Irvine, CA, is seeking a Director of Regulatory Strategy to lead global regulatory activities with emphasis on US regulatory affairs pre- and post-approval. You will serve as...  ...projects and guide IND/CTA/NDA/MAA submissions, ensuring timing and quality. The role requires... 
    Suggested

    Tarsus Pharmaceuticals, Inc.

    Irvine, CA
    1 day ago
  •  ...Glidewell Dental is seeking a seasoned Environmental Health & Safety leader to develop and manage our EH&S programs across facilities in California. You will drive compliance, risk mitigation, and alignment with business goals while coordinating cross-functional teams... 
    Senior

    Glidewell Dental

    Irvine, CA
    2 days ago
  •  ...Diality seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Moda-flx Hemodialysis System, including 510(k)s, IDEs, and international...  ...will guide cross-functional teams with regulatory strategy, ensure compliant documentation, and manage agency... 
    Senior

    Diality

    Irvine, CA
    4 days ago
  •  ...Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the...  ...the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements... 
    Senior
    Local area

    AbbVie

    Irvine, CA
    16 days ago
  •  ...Rivian is seeking a Senior Manager, Vehicle Validation to lead the SSN validation portfolio and shape strategy across multiple programs. You will guide Program Leads, coordinate cross-functional teams, and ensure robust data-backed updates on status and risk. The role... 
    Senior

    Jobleads-US

    Irvine, CA
    4 days ago
  •  ...Senior Manager Regulatory Affairs role responsible for developing and implementing US and Canada regulatory strategy for assigned pharmaceutical products, managing FDA interactions, and...  ...responses Prepare and review regulatory submissions meeting US and Canada requirements... 
    Senior

    AbbVie

    Irvine, CA
    a month ago
  •  ...Facebook,Instagram,XandYouTube. Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion combines knowledge of...  ...cosmetic Act. Development and guides implementation strategies for promotional activities Broadly applies regulatory... 
    Senior
    Work at office
    Remote work

    AbbVie

    Irvine, CA
    1 day ago
  •  ...Cordis, LLC in Irvine, CA, seeks a Senior Regulatory Affairs Specialist to lead global submissions (PMA, IDE) and shape regulatory strategy for development and marketed products. You will collaborate with engineering, QA, clinical and other teams to ensure compliance... 

    Cordis

    Irvine, CA
    1 day ago
  •  ...Balt USA in Irvine, CA is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory...  ...high-risk medical devices, oversee submissions in the US and internationally, and...  ...You will develop global regulatory strategies, interact with regulatory agencies,... 

    Balt USA

    Irvine, CA
    18 hours ago
  •  ...Madison Law APC in Orange County seeks a Senior Civil Litigation Attorney with 10+ years of experience to independently manage sophisticated litigation matters. You will develop strategy, advise clients, take and defend depositions, and handle hearings and mediations through... 
    Senior

    Madison Law, APC

    Irvine, CA
    1 day ago
  •  ...AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies to secure and maintain market approval for products. You will...  ...worldwide while ensuring alignment with senior management and business objectives. #J-18808... 
    Senior
    Worldwide

    AbbVie

    Irvine, CA
    4 days ago
  •  ...translate complex questions into data-driven analyses informing portfolio strategies, site design, resourcing, and risk management across global regions. You will build trusted relationships with senior leaders, own analytical products, and guide cross-functional teams through... 
    Senior

    AbbVie

    Irvine, CA
    2 days ago
  •  ...Rivian is seeking a Sr. Lead, Service Aftermarket Revenue Strategy to align cross-functional teams around a multi-year revenue vision....  ...own and incubate early-stage initiatives while partnering with leaders to ensure rigorous business cases and transparent dashboards. The... 
    Senior

    Jobleads-US

    Irvine, CA
    4 days ago
  •  ...experienced in-house employment attorney to advise on legal issues, strategies, and compliance. The role involves coordinating with HR,...  ...counsel of record when needed. The candidate will stay current on regulatory developments, support litigation risk management, and serve as... 
    Senior

    Columbia Bank (WA, OR & ID)

    Irvine, CA
    2 days ago
  •  ...Galderma in Irvine, CA is seeking a Senior US Medical Lead for Hyaluronic Acid Fillers....  ...Aesthetics franchise to shape the US Medical Strategy, develop scientific content, and train...  ...integrity, and engage key external thought leaders. Travel up to 10% may be required. #J-1... 
    Senior

    Galderma

    Irvine, CA
    1 day ago
  •  ...Marsh is seeking an experienced Sr. Principal Lead Health Actuary Consultant to lead client engagements in health benefits strategy, cost projections, and plan design optimization. You will mentor analysts, present findings, and serve as a key client contact in a hybrid... 
    Senior
    Work at office

    Mercer

    Irvine, CA
    3 days ago
  •  ...Project Management Office. You will shape strategy, align programs with business goals,...  ...functions. You will partner with R&D, regulatory affairs, manufacturing, quality, and marketing...  ...oversee risks, and report milestones to senior leadership. This role is based in Aliso... 
    Senior

    Terumo Neuro

    Aliso Viejo, CA
    4 days ago
  •  ...Alcon is seeking a Global Regulatory Affairs Principal Specialist to join the Regulatory Affairs team at Fort Worth...  ...Forest, CA. You will develop global regulatory strategy for new product development and direct submission work for US, EU and Canada markets. The role involves... 

    Alcon

    Lake Forest, CA
    3 days ago
  • $138.5k - $265k

     ...in? Join the #VTeamLife.The Senior Utilities Principal serves as...  ...manage the overall innovation strategy for key enterprise clients across...  ...with executive-level leaders—from C-suite to VP, including...  ...is a plus.Federal Funding & Regulatory Programs: Familiarity with DOE... 
    Senior
    Full time
    Temporary work
    Part time
    Work experience placement
    Remote work
    Shift work

    Verizon

    Irvine, CA
    2 days ago
  •  ...niche talent. Sr. Manager, Regulatory Affairs Full Time / Direct Hire In...  ...of global regulatory strategies for innovative drug/device...  ...of high‑quality regulatory submissions, ensure cross‑functional alignment...  ...(RAC) is beneficial. Seniority level: Mid‑Senior level Employment... 
    Senior
    Full time
    Work at office

    Groe Advisors LLC

    Aliso Viejo, CA
    3 days ago
  •  ...Edwards seeks a Senior Manager, Commercial Strategy to translate business needs into actionable insights and to lead sales strategy and operations. This role is onsite/hybrid at Edwards Corporate Headquarters in Irvine, CA, and offers a pathway to shape critical commercial... 
    Senior

    Edwards

    Irvine, CA
    2 days ago
  •  ...A leading medical device company is seeking a Director of Regulatory Affairs to lead regulatory strategy and submissions for invasive electromechanical devices. The ideal candidate will have over 10 years of regulatory experience, especially with 510(k) notifications... 

    Maven

    Irvine, CA
    2 days ago
  •  ...MobilityWare is seeking a Senior Product Marketing Manager to drive growth across our mobile game portfolio, leading UA creative strategy, testing, and campaigns that boost player engagement and retention. You'll drive cross-functional collaboration with Marketing and... 
    Senior

    Jump Ramp

    Irvine, CA
    3 days ago
  •  ...Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest...  ...be responsible for developing global regulatory strategy for new product development, directing submission development of product registration, progress reports... 
    Visa sponsorship
    Relocation package

    Alcon

    Lake Forest, CA
    3 days ago
  •  ...Management is seeking an Executive Director, Investment Product Specialist to lead thought leadership on capital markets and investment strategies. You will support advisor development, strengthen client satisfaction, and build deep, value-added relationships while guiding... 
    Senior

    Testing Site - JPMC

    Irvine, CA
    18 hours ago
  •  ...ERM is seeking a Senior Consultant for Air Quality Compliance Engineering or Science in Irvine, CA. The role focuses on advising clients on regulatory compliance, emissions inventories, and permitting strategies across diverse industries. Ideal candidates bring a bachelor... 
    Senior
    Local area

    Environmental Resources Management

    Irvine, CA
    18 hours ago
  • $140 per hour

     ...Job Title: Senior Teamcenter PLM Solution Architect & Discovery Lead Location: Remote within the United States, with approximately...  ...and recommendations. Data migration and CAD/ERP integration strategy, as applicable. Other discovery deliverables identified by the... 
    Senior
    Hourly pay
    Long term contract
    Full time
    Part time
    Local area
    Remote work

    Saratech

    Mission Viejo, CA
    7 days ago
  • $226.5k - $317.1k

     ...About The Role The Senior Director Regulatory Affairs Strategy will play a key role in guiding assigned projects...  ...of the role Serve as leader internally by collaborating across...  ...and execution of major regulatory submissions (US and global), global submission... 
    Senior
    Work at office
    Local area
    Remote work

    Tarsus Pharmaceuticals, Inc.

    Irvine, CA
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Leader: Strategy & Submissions. Be the first to apply!