Collecting information
Organizing data
Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. The Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dynes muscle disease programs. This role is based in Waltham, MA without the possibility of being fully remote. Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc).
Senior Director, Regulatory Affairs - Permanent - Boston, MA. Join a trailblazing biotech on the cutting edge of science and technology.. Senior Regulatory Affairs Leadership Role - Rare Disease. Reporting to the head of Regulatory Affairs, this hire will be the strategic lead across multiple programs, guiding interactions with health authorities, setting global regulatory strategy, and preparing the organization for submission and launch.. The team is mission-driven, science-first, and backed by top-tier investors.
Role: QA / Regulatory Affairs Specialist.. Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology);.. A minimum of 3 years related experience in the pharmaceutical manufacturing industry. Strong background working with Change Controls and management of change control processes. Prior regulatory affairs, quality control or quality assurance experience is a must.
The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide.. Prepare and submit global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510ks, IDEs and applicable supplements and annual reports), Canadian Class 3 Device License submissions, EU MDR Submissions, and other international markets such as Japan, Saudi Arabia, Australia and Brazil.. Support post market surveillance, including preparation of post market clinical follow up plans and reports.. 4+ years of post-internship/post graduate experience with regulatory submissions and management of Class II electro-mechanical medical devices.. Regulatory affairs experience in generating applications and experience in collaboration with internal and external partners to answer any subsequent questions.
Job Location: Swiftwater, PA. Job Description: REMOTE considered.. Possibility of extension.. Candidate to author/review/approve CMC technical documents in. s internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Auth
Join us and discover an environment in which you'll be supported to learn, grow and become your best self.. The Sr. Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance.. The Sr. Regulatory Affairs Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.. Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met.. Regulatory Affairs Professional Society (RAPS) certification preferred.
The Director of Regulatory Affairs will lead BodyBio’s regulatory strategy and execution across all product categories, including dietary supplements, functional foods, and international expansion initiatives. Oversee label revision controls, including claim language, allergen declarations, country-of-origin labeling, and documentation. Guide company adaptation to Bill 96, including French language requirements for product packaging, marketing, and websites. Texas Christian University Trial (including paperwork review and IRB coordination).. 5+ years experience in regulatory affairs within the dietary supplement, functional food, or natural health product industries.
The Senior Regulatory Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the preparation, submission, and tracking of regulatory documentation.. This position requires strong collaboration, communication, and analytical skills to support product development, market access, and post-market activities in alignment with global regulatory requirements.. Understand and apply regulatory requirements for product classification, market access, and advertising/promotion.. Familiarity with FDA, EU MDR, and other relevant international regulatory standards and regulations.. Authored regulatory submissions, such as 510ks, EU MDR technical documentation, and/or Pre-Sub notifications.
In addition to regulatory work, the Director will collaborate with Policy, Research, Federal Legislative Affairs, Public Affairs, and other colleagues on talking points, policy briefs, and infographics. A solid understanding of the regulatory and legislative processes as an underpinning for policy analysis and advocacy, including analysis of proposed legislation and statutory language and an ability to redline or draft legislative or regulatory language. ASSISTANT VICE PRESIDENT, REGULATORY AFFAIRSDirector, Regulatory Affairs - CMC (Cell Therapy).. Regulatory Affairs Director - Global Regulatory LeadGlobal Regulatory Affairs, Associate Director – UK Regulations Focus (Preferred Location: London |.. Government Affairs Deputy Director – DefenseDirector, Federal Government Affairs (Hybrid)Director CMC Policy, Advisory and IntelligenceGovernment Affairs Deputy Director - Veterans
We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, and medical aesthetic devices. Develop a product regulatory timeline aligned to Bausch Health Companies (BHC) product development, with key regulatory milestones and activities for agency filing.. Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product/dossier management lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations.. Bausch Health Companies Inc. is an Equal Opportunity Employer.
At Henkel, you’ll be part of an organization that’s shaping the future through innovation, sustainability and collaboration. This position is with our Consumer Brands business unit – where we empower our employees to bring the best Laundry & Home Care and Hair products to people around the world. Manage all regulatory affairs activities for Laundry and Dish categories in the US, including labeling, product development compliance, package development, SDS and ingredients statement generation, and ensuring consumer regulatory inquiries are addressed. Develop and implement processes and procedures to ensure regulatory compliance. Keep abreast of advancements in toxicology research to contribute to the development of safer and more sustainable products.
Senior Regulatory Affairs Associate. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers.. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.. The Senior Regulatory Affairs Associate works with faculty and staff in the Infectious Disease Sciences (IDS) Program in the Vaccine and Infectious Disease Division to ensure all regulatory compliance measures are followed for clinical trials by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues.. In partnership with the PI, prepare and track all clinical activity documents including IRB/IBC/site registration approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
Serve as the Regulatory Affairs lead on cross functional drug development teams, providing strategic input and guidance on global regulatory requirements.. 10+ years of regulatory affairs experience within the biopharma industry.. NDA and global marketing application experience highly desirable (e.g., MAA, NDS).. Industries Biotechnology Research and Pharmaceutical Manufacturing. Director, Global Regulatory Affairs, Neuroscience Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 3 weeks ago
Senza, Senza II, and Senza Omnia are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Lead and participate in regulatory strategy formulation working closely with Clinical, Market Access, R&D, and Quality teams. Generate or direct regulatory affairs specialists in the preparation of submissions (i.e. PMA, 510(k), PMA supplements, CE marking applications, product registrations, etc. Broad working knowledge of GCP, GMP, GLP. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography.
We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.. Responsibilities: Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.. Direct experience with FDA regulatory submissions required.. Background in diagnostics or biomarker development, particularly in oncology, is a plus.. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
Title: Principal Regulatory Affairs Specialist.. This position will manage all regulatory affairs activities for Laundry and Dish categories. This includes labeling, product development compliance, package development, SDS and ingredient statement generation, customer and regulatory compliance needs, consumer regulatory inquiries, and the safety and efficacy of ingredients. Stay abreast of advancements in toxicology research and contribute to the development of safer and more sustainable products. Bachelor's or graduate degree in a science-related field, law or regulatory science, business administration, or public health preferred.
A pivotal aspect of this position involves leading the strategic planning of the U.S. Biologics License Application (BLA) preparation and defense, as well as coordinating activities related to FDA Advisory Committee (AdComm) meeting preparation. Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required; an advanced degree (PhD, PharmD, MS) is strongly preferred. Experience with European MAA is preferred. Proficiency with Veeva RIM, including training others and managing regulatory commitments. Knowledge of ICH guidelines and FDA regulatory requirements.
Provide regulatory affairs support during external inspections ( FDA, BSI, etc.. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil. Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine.
We're seeking an experiencedSenior Regulatory Affairs Specialistto support global regulatory submissions and compliance initiatives. Provide regulatory guidance during FDA, Notified Body (e.g., BSI), and other regulatory inspections. Bachelor's degree with a minimum of 5 years of Regulatory Affairs experience in the medical device industry. Hands-on experience with 510(k), IDE, PMA, annual reports, MDRs, Vigilance Reports, and international registrations. Confident public speaker and collaborative team player.
The successful candidate will join Chemours’ Global Government Affairs Group with a primary responsibility for supporting U.S. federal regulatory affairs engagement with the United States Environmental Protection Agency (USEPA), as well as other select federal administrative agencies; key trade organizations that help shape regulatory policies at the U.S. federal level; and members of the U.S. Congress and their staffs.. In addition, this strategic and high-profile role will be part of the Thermal & Specialized Solutions (TSS) leadership team, focusing on advocacy of our current and future TSS product portfolio.. Liaise with the Chemours’ businesses, as well as corporate functions such as Legal, Corporate Remediation, Environmental Center of Excellence, Corporate Sustainability, Corporate Product Regulatory Compliance, Corporate Toxicology and Risk Assessment, Finance, and Communications, among others, to ensure coordination and integration of the company’s public policy agenda.. Immigration sponsorship (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status) is not currently available for this position. A global leader in industrial and specialty chemicals, our chemistry enables vital innovations from high-performance computing, artificial intelligence (AI), and advanced electronics to batteries for electric and low-emissions vehicles, climate friendly cooling, paints and durable coatings for advanced infrastructure, and more.