Current jobs related to Executive Director/Vice President, Head of Regulatory Affairs - Étreux, Hauts-de-France - MannKind

  • Senior Vice President of Regulatory Affairs

    4 weeks ago

    Étreux, Hauts-de-France, United States Fairway Consulting Group Full time

    Job Title: Senior Vice President of Regulatory AffairsJob Summary:Fairway Consulting Group is seeking a highly experienced Senior Vice President of Regulatory Affairs to lead our client's regulatory strategy. The ideal candidate will have a strong background in regulatory affairs, with experience in developing and executing global regulatory strategies.Key...

  • Regulatory Affairs Director

    4 weeks ago

    Étreux, Hauts-de-France, United States Meet Full time

    Director of Regulatory AffairsMeet is seeking a highly experienced Director of Regulatory Affairs to join their team. This role will oversee all Regulatory Strategy projects for the organization across a wide variety of therapeutic areas and modalities.Key ResponsibilitiesSupport clients with a variety of Regulatory Affairs projects (IND/CTA, NDA/BLA/MAA,...

  • Executive Director of Academic Affairs

    4 weeks ago

    Étreux, Hauts-de-France, United States University of Massachusetts Office of the... Full time

    Job SummaryThe University of Massachusetts Office of the President seeks an exceptional leader to serve as the Executive Director of Academic Affairs. This critical role will oversee the President's office review of annual tenure and promotion files, ensuring compliance with relevant Trustee policies. The successful candidate will work closely with campus...

  • Director of Regulatory Affairs

    1 month ago

    Étreux, Hauts-de-France, United States Inozyme Pharma Full time

    Job Title: Director, Regulatory StrategyAt Inozyme Pharma, we are seeking a highly experienced and skilled Director of Regulatory Strategy to join our team. As a key member of our regulatory affairs team, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs.Key...

  • Executive Vice President of Human Resources

    4 weeks ago

    Étreux, Hauts-de-France, United States Federal Reserve Bank of Boston Full time

    About the RoleThe Federal Reserve Bank of Boston is seeking a highly skilled and experienced Vice President of Human Resources and Talent Management to join our team. As a key member of our Strategic Bank Services division, you will be responsible for leading the Human Resources function to attract, develop, and retain exceptional talent in support of a...

  • Regulatory Affairs Director

    4 weeks ago

    Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Regulatory Affairs Director

    4 weeks ago

    Étreux, Hauts-de-France, United States Monte Rosa Therapeutics Full time

    Director, Regulatory Affairs - Small Molecule StrategyMonte Rosa Therapeutics is a clinical-stage biotechnology company developing innovative therapies for patients living with serious diseases in oncology, autoimmune, and inflammatory diseases, and more.The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Regulatory Affairs Director

    4 weeks ago

    Étreux, Hauts-de-France, United States Meet Full time

    Meet is seeking a seasoned Regulatory Affairs Director to lead their Regulatory Strategy projects across various therapeutic areas and modalities. This role will oversee all Regulatory Strategy initiatives, ensuring compliance and strategic alignment with the organization's goals.Key Responsibilities:Support clients with Regulatory Affairs projects,...

  • Academic Affairs Vice President

    1 month ago

    Étreux, Hauts-de-France, United States College of Charleston Full time

    Job Summary:The College of Charleston seeks a highly qualified Vice President of Academic Affairs to lead its academic programs and initiatives. This senior leadership role is responsible for overseeing the academic integrity and excellence of the institution, providing strategic direction for academic programs, policies, and initiatives, and ensuring...

  • Head of Global Regulatory Affairs Labeling

    4 weeks ago

    Étreux, Hauts-de-France, United States BioSpace, Inc. Full time

    Job SummaryThe Head of Global Regulatory Affairs Labeling will be responsible for providing guidance and oversight for the global labeling function, ensuring compliance with regulatory requirements and guidelines. This role will also involve developing and implementing global regulatory strategies, facilitating approvals, and resolving complex issues with...

  • Senior Director of Regulatory Affairs Advertising

    4 weeks ago

    Étreux, Hauts-de-France, United States EPM Scientific Full time

    Job Title: Senior Director of Regulatory Affairs AdvertisingJob Summary:A global biopharmaceutical company is seeking a Senior Director of Regulatory Affairs Advertising to join their team. The ideal candidate will have a proven track record in regulatory affairs, specifically within branded prescription products. This role is based out of either...

  • Business Execution Director

    4 weeks ago

    Étreux, Hauts-de-France, United States Wells Fargo Full time

    About the Role:We are seeking a highly skilled Business Execution Director to lead our Regulatory Affairs Reporting team. This role reports to the Chief Regulatory and Policy Affairs Executive in Regulatory and Policy Affairs (RAPA) within the Chief Operating Office.The successful candidate will be responsible for advising on and executing Regulatory...

  • Regulatory Affairs Director: Strategic Leadership for Commercial Success

    3 weeks ago

    Étreux, Hauts-de-France, United States EPM Scientific Full time

    Job Title: Senior Director of Regulatory Affairs AdvertisingJob Summary:A global biopharmaceutical company, dedicated to pursuing novel therapeutics to aid those with chronic illnesses, is seeking a Senior Director of Regulatory Affairs Ad/Promo to join their rapidly growing team. This role is based out of either Pennsylvania or Boston and offers an...

  • Strategic Leader for Equity and Access Initiatives

    2 weeks ago

    Étreux, Hauts-de-France, United States University of Massachusetts Full time

    Equity and Access Leader: Driving Inclusion at the University of MassachusettsThe University of Massachusetts seeks a visionary leader to serve as its inaugural Assistant Vice President of Equity and Access. This critical role will advise the Senior Vice President & Deputy Vice President for Academic Affairs, Student Affairs, and Equity on all issues related...

  • Associate Director, Global Regulatory Affairs Marketed Products

    4 weeks ago

    Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About the RoleWe are seeking a highly skilled Associate Director, Global Regulatory Affairs Marketed Products to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs team, you will be responsible for defining, developing, and leading global strategies to maximize regulatory success for our marketed products.Key...

  • Regulatory Affairs Senior Manager

    3 weeks ago

    Étreux, Hauts-de-France, United States Monte Rosa Therapeutics Full time

    Job Title: Senior Manager, Regulatory AffairsJob Summary: We are seeking a highly skilled and self-motivated regulatory professional to join our team. This role will focus on oncology, immunology, and related therapeutic areas.The successful candidate will be responsible for developing and implementing regulatory strategies to support the global development...

  • Regulatory Strategy Director

    4 weeks ago

    Étreux, Hauts-de-France, United States Inozyme Pharma Full time

    Director, Regulatory StrategyAbout the Role:Inozyme Pharma, a clinical-stage rare disease biopharmaceutical company, is seeking a seasoned Director of Regulatory Strategy to drive the development and execution of regulatory strategies for our rare disease therapeutic programs. As a key member of our team, you will play a critical role in navigating the...

  • Director, Regulatory Affairs CMC Small Molecules

    4 weeks ago

    Étreux, Hauts-de-France, United States BioSpace, Inc. Full time

    Job SummaryAs a Director, Regulatory Affairs CMC Small Molecules at Takeda, you will oversee the development and execution of regulatory CMC development and registration strategies. You will be responsible for leading cross-functional teams and communicating with international Health Authorities as necessary. This role requires a high level of leadership and...

  • Vice President, Account Manager, Securities Services

    1 month ago

    Étreux, Hauts-de-France, United States Hispanic Technology Executive Council Full time

    Job SummaryAs a Vice President, Account Manager, Securities Services, you will be responsible for delivering exceptional client service and ensuring that Citi is delivering a best-in-class client experience. You will act as the primary contact for operational service-related escalations and work closely with the Client Executive to ensure that client needs...

  • Senior Executive Assistant

    4 weeks ago

    Étreux, Hauts-de-France, United States Federal Reserve Bank of Cleveland Full time

    Job SummaryThe Federal Reserve Bank of Boston is seeking an experienced executive assistant to support the economic research division. In this role, the executive assistant will provide high-level administrative support to the executive vice president and director of research, manage confidential information, and coordinate schedules and delivery of products...

Executive Director/Vice President, Head of Regulatory Affairs

1 month ago

Étreux, Hauts-de-France, United States MannKind Full time
Job Summary:

MannKind Corporation is seeking an Executive Director/Vice President, Head of Regulatory Affairs to oversee the global strategy development and execution of regulatory affairs objectives. This position will be responsible for collaborating with the Clinical Team to develop and implement the US and global regulatory affairs plan across the product portfolio, overseeing the development and refinement of regulatory policies, procedures, and SOPs, and working closely with commercial, clinical development, and Medical Affairs in designing and implementing launch strategies and tactics, and life cycle planning.

Key Responsibilities:
  • Collaborate with Clinical Team to develop and implement the US and global regulatory affairs plan across product portfolio
  • Oversee development and refinement of regulatory policies, procedures, and SOPs
  • Work closely with commercial, clinical development, and Medical Affairs in designing and implementing launch strategies and tactics, and life cycle planning
  • Provide regulatory assessments of product opportunities and threats
  • Provide regulatory expertise in the development and approval of promotional materials
  • Collaborate with Commercial, Legal, and Clinical for development and review of labeling, advertising, and promotional materials
  • Lead, develop, mentor, and manage the Regulatory Affairs team
  • Develop and advance the organization's policy and procedures for regulatory affairs and compliance to maintain a compliant culture
  • Anticipate global regulatory changes and develop proactive strategies accordingly
  • Provide strategic guidance to drug development on all aspects of regulatory requirements
  • Interpret FDA (and other regulatory body) communications, expectations, and decisions to internal and external stakeholders, developing and implementing successful issue resolution strategies
  • Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
  • Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
  • Develop and plan innovative regulatory strategies for label enhancements and life cycle product management
  • Counsel and advise senior management/CMO on status of global regulatory affairs strategies and tactics, procedures, and practices and provides critical risk assessments of the strategic alternatives for regulatory filings
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
  • Provide review and approval of all external-facing communications, advertising, and promotional labeling to ensure compliance with corporate policy, US, and international laws and regulations
  • Assess project plans and timelines and ensures all projects are appropriately prioritized and key goals are met on time
  • Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidelines
  • Establish, maintain, direct, and communicate a global benefit-risk strategy for each pre-market, marketed, and future MannKind product that includes risk management and minimization
  • Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
Requirements:
  • Bachelor's degree in a scientific discipline; Graduate degree (Ph.D. or PharmD) strongly preferred
  • Progressive related experience in regulatory affairs in the pharmaceutical/biotech industry
  • Experience with designing and executing creative regulatory strategies for innovative products
  • Must have a solid understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug promotional and development processes
  • Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial
  • Experience with clinical trials and regulatory documentation is required
  • Experience with inhalation products, biologics preferred
  • Experience with post-approval change management, comparability assessment, post-marketing commitments, and overall product life cycle management
  • Excellent organizational, written, and verbal communications, project, and time management skills needed to drive multiple ongoing projects simultaneously
  • Results-driven and team-oriented with the ability to influence outcomes
  • Ability to interpret, communicate, and present regulatory information in a clear, concise, and timely manner
  • Must be able and willing to work diligently in a high-visibility, fast-paced environment with changing timelines and priorities and exhibit a passion for patients
  • Willing to travel up to 15%
Pay Range: $248,000 - $372,000 per year