Regulatory Advertising and Promotion Director

Job Title: Regulatory Affairs DirectorAt Dyne Therapeutics, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory strategy team, you will be responsible for driving forward our regulatory strategy and operational activities related to our muscle disease programs.The ideal candidate will have a strong...

Regulatory Affairs DirectorDyne Therapeutics is seeking a highly skilled Regulatory Affairs Director to lead the planning, management, and execution of regulatory activities for our product candidates in Europe, UK, and Switzerland.This role requires a strong understanding of EU regulatory requirements and the ability to develop and implement effective...

Job Title: Regulatory Affairs DirectorJob Summary:We are seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and ensure compliance with regulatory requirements. The successful candidate will have a strong background in pharmaceutical industry experience, with a focus on regulatory affairs leadership roles.Key...

About the Role:Syndax Pharmaceuticals is seeking an Executive Director, Regulatory Operations to formulate and implement a regulatory operations vision and strategy for a commercial stage biotechnology company.The ideal candidate will be responsible for envisioning and implementing a fit-for-purpose Regulatory Information Management (RIM) system across...

Job Description:The Director of Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in assigned therapeutic areas.Key Responsibilities:Leads the Global Regulatory Product Team (GRPT) to develop creative global strategies in line with applicable regulations to achieve...

Job Title: Associate Director, Regulatory Affairs CMCCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to...

Job Description Overview: Alkermes is a global biopharmaceutical company dedicated to developing innovative treatments for complex and difficult-to-treat psychiatric and neurological disorders. We are seeking an experienced Associate Director of CMC Regulatory Affairs to join our team in Waltham, MA. Key Responsibilities:Develop and lead regulatory CMC...

Job SummaryAlkermes is seeking a highly skilled Associate Director to lead our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory strategies and guidance on post-approval CMC topics.Key ResponsibilitiesDevelop and lead regulatory CMC...

Job SummaryMythic Therapeutics is seeking a highly experienced Director/Senior Director of Regulatory Chemistry Manufacturing and Controls (CMC) to join our growing Regulatory Affairs team. This role will report to the Vice President Regulatory Affairs and will closely collaborate with Technical Operations, Quality, Clinical Operations, and other functions...

Job DescriptionDragonfly Therapeutics, Inc. is seeking a highly skilled Regulatory & Medical Affairs professional to lead our Regulatory Affairs organization.The ideal candidate will have a strong background in regulatory strategy and a proven track record of implementing innovative approaches to achieve regulatory milestones and business objectives.Develop...

Job DescriptionAbbVie's MissionAbbVie is committed to discovering and delivering innovative medicines and solutions that address serious health issues today and tomorrow.We strive to have a remarkable impact on people's lives across key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...

Job DescriptionDeciphera Pharmaceuticals, a biopharmaceutical company, is seeking a highly skilled Regulatory CMC Senior Manager to join its growing Post-Approval Group within the Regulatory Affairs Organization. The primary responsibility of this position is to lead and execute post-approval CMC regulatory activities in support of Deciphera's globally...

Job OverviewMadrigal Pharmaceuticals Corporation seeks a seasoned IT professional to serve as the Senior Director of IT for Patient Services. This strategic leadership role will oversee the implementation and enhancement of IT systems supporting Patient Services functions, including Patient Support platforms, CRM and communication tools for the Access &...

Job Title: Associate Director IT Validation LeadDyne Therapeutics Inc is seeking an experienced Associate Director IT Validation Lead to lead the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments.This role focuses on the development,...

Job Title: Clinical Development DirectorJob Overview: Stratacuity is seeking a Clinical Development Professional to strategize, plan, and manage clinical activities for cancer immunotherapy development in a dynamic, team-oriented environment.Key Responsibilities:Design early-phase clinical trials for novel cancer treatments and write trial documents.Assist...

Job SummaryThe Associate Director of IT Validation leads the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments.This role focuses on the development, execution, and management of IT validation strategies and initiatives for systems...

Job Summary:The Associate Director, Clinical Business Operations will provide support for vendor outsourcing and financial oversight for Dyne's clinical trials. This role is responsible for ensuring efficient, accurate clinical trial financial management including forecasting, reporting, and oversight of vendor spend. The Associate Director, Clinical...

Job DescriptionSobi is seeking a highly skilled Medical Director to lead our clinical development activities for a therapeutic area. As a key member of our team, you will be responsible for managing and reviewing clinical trials, as well as providing medical input on regulatory documents and business development initiatives.The ideal candidate will have a...

Job SummaryBoston Scientific is seeking a highly skilled Design Assurance Director to lead our Electrophysiology Systems team. As a key member of our organization, you will be responsible for ensuring product quality and compliance through the application of Design Control and Risk Management.Key ResponsibilitiesLead quality team on product/system...

ElevateBio is a technology-driven cell and gene therapy company accelerating access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role: ElevateBio is...