We have other current jobs related to this field that you can find below
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Senior Director, Regulatory Strategy
3 days ago
Boston, United States Vertex Pharmaceuticals Full timeSenior Director, Regulatory StrategyJob DescriptionGeneral Summary:The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies...
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Associate Director, Regulatory Affairs
4 weeks ago
Boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Associate Director, Regulatory Affairs
4 weeks ago
Boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Associate Director, Regulatory Affairs
2 days ago
boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Associate Director, Regulatory Affairs
4 weeks ago
Boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Boston, United States Inozyme Pharma Full timeCompany Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are...
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Boston, United States Inozyme Pharma Full timePosition Overview: As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with...
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Boston, Massachusetts, United States Inozyme Pharma Full timeCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing...
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Boston, Massachusetts, United States Inozyme Pharma Full timePosition Overview:As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory...
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Senior Director, Regulatory Strategy
3 days ago
Boston, United States Vertex Pharmaceuticals Incorporated Full timeJob DescriptionGeneral Summary:The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in...
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Director of Regulatory Affairs
2 days ago
boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Director of Regulatory Affairs
19 hours ago
boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Director of Regulatory Affairs
1 week ago
Boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Director of Regulatory Affairs
1 week ago
Boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Analytical CMC Strategy Associate Director
3 days ago
Boston, United States Vertex Pharmaceuticals Incorporated Full timeJob DescriptionGeneral Summary:Vertex Pharmaceuticals is seeking a highly motivated, collaborative, and innovative Associate Director specializing in analytical CMC strategy to provide scientific leadership within and across functional areas. The Analytical CMC Strategy Associate Director is the primary analytical liaison for their program(s) and will lead,...
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Director of Regulatory Affairs
3 months ago
Boston, United States JRG Partners Full timeJob DescriptionJob DescriptionJob Title: Director of Regulatory AffairsJob Description:As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that our products comply with all applicable regulatory requirements and standards. Leveraging your extensive knowledge of regulatory processes, you will lead the...
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Associate Director, Regulatory Affairs CMC Writer
2 months ago
Boston, United States Pharvaris Full timePharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple...
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Associate Director, Regulatory Affairs CMC Writer
2 months ago
Boston, United States Pharvaris Full timePharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple...
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Boston, United States Vertex Pharmaceuticals Full timeAssociate Director, Regulatory Submission ManagementJob DescriptionThe Associate Director, Regulatory Submission Management is responsible for the planning, managing, and tracking of the regulatory portfolio of submissions across a number of assigned programs. This role will be responsible for driving comprehensive plans and reports that would include all...
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Director, Regulatory Labeling
1 day ago
Boston, United States Proclinical Staffing Full timeDirector, Regulatory Labeling - Permanent - BostonAre you a creative regulatory leader ready to shape the future of respiratory products? Proclinical is collaborating with a pioneering pharmaceutical company that is seeking a Director of Regulatory Labeling to spearhead the delivery of cutting-edge labeling for key products in the US and major global...
Associate Director, Regulatory Strategy
2 months ago
Associate Director, Regulatory Strategy page is loaded Associate Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22153 Job DescriptionThe Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or commercial product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s). This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development.Key Duties and Responsibilities:Leads the development and implementation of global regulatory strategy for assigned projects in development through commercial stagesContributes to and may lead the development and implementation of regional regulatory strategy to inform the global strategy for certain projectsLeads regulatory communications and interactions with health authoritiesAdvises teams on regulatory requirements for development and approval pathways, including potential for expedited pathwaysLeads and oversees the process for preparation, submission, and approval of regulatory applicationsProvides strategic and technical regulatory input for key product development or registration documentsEnsures compliance of regulatory submissions with current regulations and guidanceReviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategyAdvises cross-functional teams and senior management on regulatory risks, considerations, and strategies for program(s)Acts as an advisor and coach to mentor members of the teamKnowledge and Skills:Specialized knowledge of global and regional regulatory affairs frameworks and guidelinesComprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacologyComprehensive understanding of requirements and processes to maintain a product on the market, product labeling, reporting, and surveillanceAbility to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessmentStrong problem-solving skillsStrong written and verbal communication skills, tailored to multiple audiences, to communicate difficult concepts and persuade others to adopt a different point of viewAbility to effectively lead and work within a team environmentPrior experience with major health authority submissions and health authority interactions is required.Education and Experience:Bachelor's degree in Biology, Chemistry, or other related disciplineTypically requires 8 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experienceWe're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:1. Hybrid and work remotely up to two days per week; or select2. On-Site and work 5 days per week with ad hoc flexibility. #LI-Hybrid #LI-AR1 Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ******. Similar Jobs (5) Senior Director, Regulatory Strategy locations Boston, MA time type Full time posted on Posted 21 Days Ago Senior Director, Regulatory Strategy locations Boston, MA time type Full time posted on Posted Yesterday Director, Regulatory Strategy locations Boston, MA time type Full time posted on Posted Yesterday Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram . The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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