Director, PV Regulatory

6 days ago


Cambridge, Massachusetts, United States ONO PHARMA USA Full time
Job Summary

ONO 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 Responsibilities
  • Develop and implement PV strategies to ensure compliance with regulatory requirements
  • Provide expert guidance to cross-functional teams on PV regulatory matters
  • Collaborate with internal stakeholders to ensure effective communication and coordination
  • Stay up-to-date with regulatory changes and developments
  • Develop and maintain relationships with regulatory authorities
Requirements
  • 10+ years of experience in PV Regulatory Affairs, with a strong background in pharmaceuticals
  • Proven track record of success in leading PV Regulatory Affairs teams
  • Excellent communication and interpersonal skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
  • Strong knowledge of regulatory requirements and guidelines
Preferred Qualifications
  • Master's degree in a relevant field (e.g. pharmaceutical sciences, regulatory affairs)
  • Experience working in a pharmaceutical company
  • Knowledge of regulatory requirements in multiple regions (e.g. US, EU, Japan)
What We Offer
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment


  • Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director, PV Quality to provide quality oversight of our pharmacovigilance system and support the development of quality and compliance strategies for global pharmacovigilance activities.Key ResponsibilitiesDevelop and implement quality and compliance strategies for pharmacovigilance activitiesConduct audits...

  • 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 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 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 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 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 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...


  • Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job Title: Associate Director, Regulatory Strategy About the Role: We are seeking an experienced Associate Director to lead our regulatory strategy efforts. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to support the development and approval of our gene therapies. Key...


  • 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 Alkeus Pharmaceuticals, Inc. Full time

    About Alkeus PharmaceuticalsWe are a late-stage biopharmaceutical company dedicated to developing transformative therapeutics for serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA)...


  • 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 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...