Director, US Regulatory Advertising and Promotion

2 weeks ago


Cambridge, Massachusetts, United States Ipsen Pharma Full time
Job Summary

The Director, US Regulatory Advertising and Promotion will be responsible for leading the review and approval of promotional and medical communications for assigned brands. This role will also involve interacting with the FDA Office of Product and Drug Promotion and overseeing OPDP submissions.

Main Responsibilities

Responsibilities will include, but are not limited to, the following:

  • Providing regulatory advice and guidance on FDA advertising and promotion issues for assigned products
  • Developing and implementing SOPs and work instructions to facilitate streamlined workflows and encourage proficient practice of process policy
  • Liaising with OPDP/FDA as needed for assigned products, serving as the company's single point of contact with FDA on matters related to advertising and promotional materials
  • Collaborating with partner functions to share commercial regulatory guidance on US Commercial Teams' strategic imperatives
  • Leading PRC teams in management of tasks that help support compliant execution of Marketing tactics and programs

Requirements

The ideal candidate will have a minimum of 8 years of experience in the pharmaceutical industry and a minimum of 6 years in regulatory affairs. Expert knowledge of advertising promotion regulations and FDA Guidance documents is required, as well as solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters. Overseeing OPDP submissions and authoring all submissions for assigned products is also a key responsibility of this role.

Key Technical Competencies

The successful candidate will have excellent oral and written communication and negotiation skills, with a strong attention to detail. Seasoned ability to spot issues and convey unique product facts, offering ideas and options as guidance to mitigate risks is also essential. Ability to influence and interact effectively across relevant functions within Ipsen and with regulators is required. Demonstration of understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards is also necessary.
  • Regulatory Director

    2 weeks ago


    Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    {"title": "Regulatory Director", "content": "Job SummaryONO PHARMA USA is seeking a highly skilled Regulatory Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to enhance our organizational capabilities.Key...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    About the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.Job DescriptionThe Director/Senior Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy....


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    Job SummaryONO PHARMA USA is seeking a highly experienced and skilled Director, PV Regulatory to lead our Pharmacovigilance (PV) Regulatory Affairs function. The successful candidate will be responsible for ensuring compliance with regulatory requirements, developing and implementing PV strategies, and providing expert guidance to cross-functional teams.Key...


  • Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Job Title: Regulatory Affairs DirectorGlaxoSmithKline is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regional regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.Key...


  • Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    Associate Director of Regulatory Affairs Job DescriptionAt PSG Global Solutions Careers, we're seeking a highly skilled Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market.Develop and...


  • Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Senior Director, Regulatory StrategyProclinical Staffing is seeking a seasoned professional to lead the development and execution of regulatory strategies for a global biotech company. The ideal candidate will have a strong background in regulatory affairs, with a focus on vaccine development and mRNA platform technology.Key Responsibilities:The Senior...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    {"title": "Regulatory Affairs Director", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will be responsible for establishing and communicating regulatory strategies for development programs and coordinating the timelines, generation, and...


  • Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Job Title: Associate Director, Regulatory OperationsAkebia Therapeutics is seeking an experienced Associate Director, Regulatory Operations to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing all regulatory operations activities, including project submission management, Smartsheet or MS project...


  • Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Job Title: Director, Global Regulatory AffairsGlaxoSmithKline is seeking a highly skilled and experienced Director, Global Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and leadership on regulatory matters related to our RNA vaccines.Key...


  • Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Regulatory Operations DirectorAkebia Therapeutics is seeking a highly skilled Regulatory Operations Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the accuracy and timeliness of regulatory documentation, as well as providing guidance to the department to meet its application filing...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Cullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Job Title: Associate Director Regulatory StrategyAgios Pharmaceuticals is seeking an experienced Associate Director of Regulatory Strategy to join our growing Regulatory team. As a key member of our team, you will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across...


  • Cambridge, Massachusetts, United States Apnimed Full time

    {"title": "Senior Director of Regulatory Affairs", "content": "Job SummaryApnimed is seeking a highly experienced Senior Director of Regulatory Affairs to lead the development and execution of regulatory strategies to support the approval and commercialization of our therapies globally.This is a key role in advancing our innovative programs through clinical...


  • Cambridge, Massachusetts, United States Apnimed Full time

    Job Title: Senior Director, Regulatory AffairsApnimed is a clinical-stage pharmaceutical company dedicated to transforming the treatment of sleep apnea. We are seeking a highly experienced Senior Director of Regulatory Affairs to play a key role in advancing our innovative programs through clinical trials and commercialization globally.Key...


  • Cambridge, Massachusetts, United States Takeda Full time

    Regulatory Affairs Director, Small MoleculesTakeda is seeking a highly experienced Regulatory Affairs Director, Small Molecules to lead our Global Regulatory Affairs CMC team. As a key member of our team, you will be responsible for overseeing the development and execution of regulatory CMC development and registration strategies.Key Responsibilities:Plan,...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    Job SummaryWe are seeking an experienced Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will establish and communicate regulatory strategies for development programs and coordinate the timelines, generation, and submission of complex regulatory dossiers.Key ResponsibilitiesManage the planning,...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will serve as a Health Authority liaison and establish and communicate regulatory strategies for development programs.Key ResponsibilitiesManage the planning, preparation, and submission of regulatory dossiers...


  • Cambridge, Massachusetts, United States Philips Full time

    Job SummaryWe are seeking a highly experienced Director of Regulatory Affairs and Quality to lead our Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities.Key ResponsibilitiesLead the development and execution of regulatory and quality strategies to maintain current...


  • Cambridge, Massachusetts, United States Sarepta Therapeutics Full time

    About the RoleSarepta Therapeutics is seeking a highly skilled Regulatory Strategy Director to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on regulatory matters and ensuring compliance with global regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory...


  • Cambridge, Massachusetts, United States Takeda Full time

    Director, GRA CMC Small MoleculesTakeda is seeking a highly skilled Director, GRA CMC Small Molecules to lead the development and execution of regulatory CMC development and registration strategies. As a key member of the Global Regulatory Affairs CMC team, you will oversee the development and execution of regulatory CMC development and registration...