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The Sr. 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.. Skills : Familiarity with FDA, EU MDR, and other relevant international regulatory standards and regulations.. Authored regulatory submissions, such as 510ks, EU MDR technical docuntation, and/or Pre-Sub notifications.
Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.. Provides regulatory leadership and strategic direction in support of the development, registration, and life-cycle management of Annexon products including collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, Manufacturing and Quality to define and implement global regulatory strategies for Annexon's novel assets across IND/CTA, NDA/BLA or MAA filings in US, EU, and other regions.. PhD/PharmD with 15+ years' experience in Regulatory Affairs or BS/MS/MSN with 18+ years' experience.. Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities. Traumatic brain injury
The Head of Regulatory Affairs leads regulatory strategy and operations across this biotech's development programs.. Biotechnology Research and Pharmaceutical Manufacturing. Regulatory Affairs Director - Oncology Cell & Gene Therapy. Head of Compliance and Enterprise Risk Management. TA HEAD, GLOBAL HEOR | multiple clinical assets - build team | seeking SD / ED / VP | Renowned Boston Pharma
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.. Pulmonx is looking for a Sr Regulatory Affairs Specialist to join our team supporting all regulatory aspects of our groundbreaking medical devices.. If you enjoy a mix of both tactical and strategic hands-on work with a strong group of Regulatory Affairs experts, please apply!. Stay current with industry trends and best practices in international regulatory affairs.. Minimum of 3-5 years of experience in regulatory affairs, specifically with Class II or Class III medical devices.
Bachelors degree in life sciences or a related discipline required; advanced degree (PharmD) strongly preferred. Minimum 2-4 years of experience in regulatory affairs within the biotech or pharmaceutical industry strongly preferred. Bicaras lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-).. Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF- signaling within the tumor microenvironment.. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types.
The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by PROCEPT BioRobotics (company) from development through marketing approval and commercialization.. The initial role of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs.. Knowledge of EU MDR regulations is required. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procepts history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do.. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
The incumbent might also be designated as U.S. Agent (back-up) for the U.S. Office for both ANDAs (GPI USA) and API (GLS India).. Support the U.S. Office for more than 170 approved ANDAs and all unapproved (under review ANDAs) as U.S. Agent back-up for all Glenmark subsidiaries including GPL, GSSA, GPI and GLS. The successful candidate will need to be able to review and sign various submissions to FDA. It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to ANDAs and/or Supplements to post-approval work.. The email list is provided for such communications which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management, Demand Planning, Marketing and others identified on the list.. Separate communications received from the FDA to support GLS will be sent to the GLS leadership team as identified.. B.S. in Chemistry or Biology, or Engineering degree in Biotechnology or Chemical Engineering
Looking for candidates local to the Maple Grove MN or St Paul MN area. The Global Regulatory Services (GRS) Quality Compliance Project Lead is responsible for supporting the RA procedure harmonization and related maintenance activities post harmonization. Regulatory processes have been harmonized across 6 Client medical device business units Support GRS own
Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. Principal Regulatory Affairs Specialist.. Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements.. For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. Actual wage offered may vary depending on work location , experience, education, training, external market data, internal pay equity, or other bona fide factors.
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 Dyne's 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).
ResponsibilitiesLead and execute global regulatory strategies, including 510(k), IDE, and PMA submissions.. Proven track record with U.S. and global regulatory submissions, including PMA and 510(k).. Vice President, Regulatory Affairs (Clinical)Head, Ethics & Compliance, Global Oncology BU. Ethics & Compliance Business Partner, Dermatology. Executive Director, Senior Corporate Counsel
Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise and executional leadership.. 7+ years or equivalent relevant experience in regulatory affairs in the biopharmaceutical industry. Hands-on experience preparing and managing IND / CTAs and related submissions required; NDA / MAA experience a plus. Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity.. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.
Postgraduate degrees relevant to the role ( e.g. MSc, PhD , PharmD, MD ) a plus. Experience working in regulatory documentation system (like Veeva). When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines!. At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines.. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives.
The Senior Regulatory Affairs Specialist (Advertising & Promotional Review) leads the end-to-end review process for promotional and non-promotional content across Stallergenes Greer portfolio of products.. Ensures all materials comply with Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and Office of Prescription Drug Promotion (OPDP), and other regulatory requirements while fostering a culture of collaboration and compliance.. Manage end-to-end workflows within Veeva PromoMats, including metadata validation, reviewer assignment, tier classification, and final sign-off processes.. 3 - 5 years’ experience in biopharmaceutical and/or medical device Regulatory Affairs, with specifically 1+ year in advertising and promotional review.. Proven experience working with Veeva PromoMats and supporting submissions to CBER/OPDP.
Wixon, a respected and innovative flavor and spice manufacturer based in Southeast Wisconsin, is seeking a Director of Regulatory Affairs to lead our efforts in regulatory compliance, food safety, and product labeling.. Oversee compliance with Kosher, Halal, Organic, Non-GMO Project Verified, and Gluten-Free programs.. Represent Wixon in regulatory interactions with customers and government agencies; lead crisis management for product recalls or withdrawals.. Manage departmental budgeting, performance tracking, and technology systems including IFS, Optiva, Genesis (Trustwell), and more.. Our corporate campus in St. Francis, Wisconsin, visit our website for more company information at
The Specialist SRA leverages technical expertise for the execution of global raw material compliance, regulatory data management and digital transformation to unlock value and efficiency. This position partners externally with Mars’ suppliers and internally with Product Development, Commercial, Legal, SQA, Activity Management and Digital teams to provide regulatory support to enable innovation. The Specialist supports SRA’s mission and vision to transform our compliance operating model, consisting of harmonized processes, global data governance and automation, to modernize how we ensure compliance and enable growth. Bachelor’s degree in nutrition, biochemistry, food science, food safety, food process engineering or equivalent.. Global Compliance Management:Executes the global raw material review and data management process for Mars Wrigley, ensuring compliance with regulatory information related to nutrition, ingredient composition, claims suitability and allergen labeling.
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.. Discounts on local sports games, fitness gyms and attractions. Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility. Get notified about new Regulatory Affairs Project Manager jobs in Cincinnati, OH. Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc.
This person will report to the Global Regulatory Operations – Quality & Compliance Senior Manager.. These activities include: managing GRS CAPA tracker, quality review for verification, lead CAPA correction and corrective action delegated activities and tasks.. Develop, redline, and compile feedback on GRS owned procedure, work instructions, forms, and templates. Windchill experience (not required, but a plus). Delta Dental plan with 2 free cleanings and insurance discounts
The Senior Regulatory Affairs Manager will provide direct regulatory support for IVD cancer screening products (Shield CRC and future blood-based cancer screening tests) in all stages of the product lifecycle. Qualifications Bachelor's degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role, preferably in molecular diagnostics or closely related area; OR an advanced degree with at least 5 years of relevant experience in an IVD regulatory affairs role. Proven success in authoring and leading FDA regulatory submissions and interactions, including PMAs, sPMAs, 30-Day Notices, 510(k)s, and IDE submissions. Proficient with Microsoft Office, Propel, JIRA, Teams, Confluence, and AI tools is a plus. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).
Ensure accurate and up-to-date product documentation (SDS, AQDS, VOC Data Sheets, etc. Cross-functional Coordination & Reporting Collaborate with R&D, Production, and Commercial teams to ensure product conformity with federal, state, and local regulations, including VOC/HAP content, FDA Title 21, and hazard communications.. Raw Material Management & System Maintenance Evaluate hazards of new raw materials and ensure SDS availability per OSHA requirements.. 10+ years of experience in the coatings, chemicals, or regulatory compliance industry.. Familiarity with Mexico labeling/marking requirements and regulations from CARB, SCAQMD, EPA, TSCA, and DSL.