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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!
We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs).. Serve as a subject matter expert on regulatory systems (e.g., Veeva Vault), overseeing system use in collaboration with IT and Quality, user training and data archiving.. 7+ years of experience in regulatory affairs with a strong emphasis on early-phase drug development.. Are you currently or have you ever been excluded or debarred by the OIG, DOJ, FDA, or any other Federal or State agency?. Do you have experience in regulatory affairs within Oncology with a strong emphasis on early-phase drug development?
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.
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.
Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. The Senior Director, Regulatory Affairs is a strategic and operational leader responsible for overseeing regulatory strategy, execution, and compliance across all phases of drug development but with a primary focus on early-stage first-in-human / first-in-class molecules. The Senior Director will lead a team of Regulatory Affairs professionals and serve as the primary liaison with global health authorities, including the FDA, EMA, and Health Canada. Deep knowledge of Health Canada and FDA regulatory frameworks, including CTA and IND processes. Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
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
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 medicines greatest challenges. 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.
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 Senior Director, Regulatory Affairs is a key strategist, responsible for developing regulatory strategy for the Endoscopy business unit and delivering Strykers best-in-class visualization and connectivity products to market in the United States, Canada and Europe.. Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes.
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.
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.
Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond. This role is responsible for the development and execution of regulatory strategy across all functions, including preclinical and clinical development, CMC, and eventual commercialization. Partner with internal stakeholders (R&D, CMC, Clinical Operations, Corporate Strategy, Legal, etc. Minimum of 15 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including at least 8 years in leadership roles. Deep understanding of regulatory guidance, quality standards (GxPs), and global health authority expectations across therapeutic modalities, with emphasis on RNA, lipid nanoparticle, gene, or cell therapy platforms.
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).
Support regulatory intelligence and policy priorities based on Alexion and AstraZenecas internal knowledge and expertise.. Postgraduate degrees relevant to the role ( e.g. MSc, PhD , PharmD, MD ) a plus. Experience working in regulatory documentation system (like Veeva). 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.
Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical research and drug discovery organization that was formed in 2007 when SUN Pharmaceutical Industries Ltd separated out its active projects in drug discovery and innovation into a new company to provide the focus and the opportunity for growth of these projects which are now at different stages of preclinical and clinical development. SPARC is seeking a Senior Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ. The position is to provide regulatory affairs strategic leadership for SPARC and supported Sun novel drug development programs. The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company. Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory
Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.. This role is responsible for the development and execution of regulatory strategy across all functions, including preclinical and clinical development, CMC, and eventual commercialization.. Partner with internal stakeholders (R&D, CMC, Clinical Operations, Corporate Strategy, Legal, etc.. Minimum of 15 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including at least 8 years in leadership roles.. Deep understanding of regulatory guidance, quality standards (GxPs), and global health authority expectations across therapeutic modalities, with emphasis on RNA, lipid nanoparticle, gene, or cell therapy platforms.
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.
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