Senior Manager, US Medical Affairs Dyne Therapeutics IncSenior Manager, US Medical AffairsWaltham, MA$165,000–$190,000 / yearThe company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. This role contributes to critical launch readiness activities and supports the planning and delivery of US Medical initiatives, including KOL engagement, congress execution, medical education efforts, and cross-functional coordination.
Associate Director, Clinical Science Deciphera Pharmaceuticals IncAssociate Director, Clinical ScienceWaltham, MA$171,000–$236,000 / yearROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Sr. Regulatory Affairs Specialist Glaukos CorpSr. Regulatory Affairs SpecialistBurlington, MAOur constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Director, RA Global Regulatory Strategy AbbVie, IncDirector, RA Global Regulatory StrategyWaltham, MAThe Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position.
Clinical Affairs Scientist Agilent Technologies IncClinical Affairs ScientistMA$105,280–$197,400 / yearThe candidate will work directly with pharmaceutical partners, R&D scientists, Clinical Trial Managers/ Clinical Research Associates, Quality Assurance, and Regulatory Affairs to assure compliance with internal and external requirements. We are searching for an experienced Clinical Affairs Scientist (CAS) to work within the medical diagnostic field as a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team.
Head of Global Labeling CSL Behring LLCHead of Global LabelingWaltham, MAYou'll set global labelling strategy, balancing business need against the core obligation of getting benefit/risk information right for the people relying on it, and you'll ensure the underlying processes deliver accurate, timely labelling information that supports the safe and effective use of Seqirus' products, importantly, including the regulatory requirements around timely safety-related updates. You'll work closely with cross-functional stakeholders including Global Safety, Clinical Development, Commercial and Supply Chain to ensure effective and timely labelling deliverables meet business needs across every region Seqirus operates in.
Associate Scientific Director Medical Affairs - Gynecologic Tumors AbbVie IncAssociate Scientific Director Medical Affairs - Gynecologic TumorsWaltham, MAWorking under the leadership of the Senior Director, this position supports the development and execution of the therapeutic area medical strategy including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Director, Global Regulatory Labeling Strategy Takeda Pharmaceutical Co LtdDirector, Global Regulatory Labeling StrategyMARemote$177,000–$278,080 / yearConducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
Director RA Global Regulatory Strategy AbbVie IncDirector RA Global Regulatory StrategyWaltham, MAThe Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position.
Medical Director, Clinical Science – Thoracic Oncologyence 3316 Takeda Development Center AmericasMedical Director, Clinical Science – Thoracic OncologyenceBoston, MassachusettsThe Medical Director, Clinical Science – Thoracic Oncology provides medical and scientific leadership for the design, execution and interpretation of global clinical studies within Takeda’s thoracic oncology portfolio, spanning non-small cell lung cancer, small cell lung cancer and other intrathoracic malignancies. Reporting to the Executive Medical Director, Oncology Clinical Sciences, the role partners with the Clinical Development lead to translating program strategy into high-quality protocols, robust data and regulatory-grade deliverables that advance assets from first-in-human through registrational studies and lifecycle expansion.
Associate Director, Regulatory Affairs - Advertising/Promotion (REMOTE) MannKind CorpAssociate Director, Regulatory Affairs - Advertising/Promotion (REMOTE)Boston, MARemoteAdditional key job duties and responsibilities are as detailed below and will include: Providing strategic advice on advertising and promotional activities for assigned products in accordance with business goals and objectives, Maintaining current knowledge and understanding of FDA regulations/guidelines PhRMA guidelines and company policy and sharing new developments with impacted team members, Informs teams for assigned products and projects on implementation of compliant product labeling and communications. Job Summary: The Associate Director, Regulatory Affairs will be responsible for coordinating and completing regulatory review and approval of all commercial materials, representing the Regulatory team on both the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.
Regional Government Affairs Director - Northeast ModivCare Inc.Regional Government Affairs Director - NortheastLynn, MA$159,900–$215,900 / yearThe position will design and implement state-level advocacy strategies aligned with enterprise priorities and will manage engagement with key stakeholders and execution of public affairs initiatives as directed and designed in collaboration with Corporate Affairs leadership. Serves as the companys primary representative at the assigned state capitols before executive leadership, including Medicaid directors, transportation program leaders, and personal care services (PCS) administrators.
Associate Director, US Strategic Business Planning & Execution, Medical Affairs Alexion Pharmaceuticals IncAssociate Director, US Strategic Business Planning & Execution, Medical AffairsBoston, MA$150,098.40–$225,147.60 / yearThis is what you will do: The Associate Director Strategic Planning & Execution, US Medical Affairs is responsible for the execution of strategic initiatives within the US Medical Affairs organization and will partner with TA Leadership teams and cross functionally to execute on projects in line with the functions overall strategic goals. You will be responsible for: Strategic Partnership: Develop annual enterprise strategy for assigned TA and/or Function and ensure effective, efficient, and equitable delivery of key strategic programs and operational activities.
Senior Director, Medical Writing AgomAb Therapeutics NVSenior Director, Medical WritingCambridge, MAAuthor and lead the development of core regulatory and clinical documents across all programs, including clinical study protocols (Phase 1-3), clinical study reports (ICH E3), investigator''s brochures, regulatory agency briefing documents (FDA Type C/D, EOP2, PreIND), scientific advice packages (e.g., MHRA, EMA), and pediatric plans (PIP/iPSP). Expertise and thorough knowledge of regulatory requirements and technical specifications for the assembly, structure, content, formatting, quality control, and submission of all document types within the CTD process, including management of associated health authority requests.
Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co LtdExecutive Director, Global Regulatory Affairs CMC Early DevelopmentBoston, MA$238,000–$374,000 / yearAccountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator's brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).
Associate Director, Advertising and Promotional Compliance, US Alexion Pharmaceuticals IncAssociate Director, Advertising and Promotional Compliance, USBoston, MA$150,000–$200,000 / yearThe Associate Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials. Our positions offer eligibility for various incentives\u2014an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
NewEnvironmental Materials and EPR Program Compliance Manager 6149-DePuy Synthes Products Legal EntityEnvironmental Materials and EPR Program Compliance ManagerRaynham, Massachusetts$117,000–$201,250 / yearBusiness Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team Management The anticipated base pay range for this position is: DePuy Synthes is recruiting an Environmental Materials and EPR Program Compliance Manager to lead global Product Stewardship compliance for electrical and electronic equipment, e-waste, batteries, packaging, plastics, environmental reporting, fees, and Extended Producer Responsibility (EPR) take-back schemes.
Senior Director, Clinical Research, Atherosclerosis Merck & Co IncSenior Director, Clinical Research, AtherosclerosisBoston, MA$173,200–$272,600 / yearWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies.
Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product Takeda Pharmaceutical Co LtdExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination ProductBoston, MA$238,000–$374,000 / yearAs Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. How you will contribute: Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.
Director, Drug Safety & Pharmacovigilance Scientist Dyne Therapeutics IncDirector, Drug Safety & Pharmacovigilance ScientistWaltham, MA$220,000–$240,000 / yearRole Summary: The Director, Drug Safety & Pharmacovigilance Scientist provides strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management activities across Dyne's development programs. The Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making.