Collecting information
Organizing data
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team’s activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization.. Effectively negotiate alignment with Otsuka parent and affiliate organizations on strategy & messaging to produce optimal outcomes from global health authority interactions.. Define and oversee phase-appropriate CMC regulatory strategy for biologics, including CMC regulatory-specific risk mitigation, and ensuring seamless progression from discovery through early clinical development.. Support CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) pertaining to the preparation and content of CTA / IMPDs, PPQs, INDs dossiers to ensure timely delivery of final documents to be included in submissions.. 15+ years of global regulatory affairs experience, including at least 5 - 7 years in biologics, with expertise in early-stage development (IND-enabling, FIH, PoC), CMC regulatory strategy, and global compliance.
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).
The Senior Regulatory Affairs Specialist responsibilities encompass to work with corporate RA, R&D, Marketing, Legal, Business Leader and any other relevant department to compile technical information for supporting regulatory submissions for the countries of the region.. Compile appropriate technical documents and author local regulatory submissions for FDA and Health Canada.. Bachelors Degree required, preferably in STEM/Medicine/Life Science.. Masters Degree in Regulatory Affairs preferred.. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms.
We are passionate about advancing scientific discoveries to become important medicines for rare disease patients.. The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization of novel liver drugs including quality, preclinical and clinical areas of drug development.. The role is responsible for ensuring full regional regulatory compliance, and overseeing submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA. Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.. Experience with regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), post marketing measures, Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities).
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).
Proven track record with U.S. and global regulatory submissions, including PMA and 510(k). Director/Senior Director, Corporate Counsel.. Head, Ethics & Compliance, Global Oncology BU. Ethics & Compliance Business Partner, Dermatology.. Executive Director, Senior Corporate Counsel
Meet has partnered with an exciting, pre-IPO biotech that is developing treatments for hematological conditions utilizing an innovative cell therapy platform. You will lead the planning and development of key regulatory submissions (IND/CTA, BLA/MAA) with cross-functional team members. Experience leading programs from IND/CTA through BLA/MAA required.. Sr. Director Regulatory Affairs Early Development Lead Head of Quality Assurance & Regulatory Affairs Associate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 2 weeks ago.. Executive Director/Vice President, Regulatory Affairs Associate Director, Global Regulatory Affairs, Advertising and Promotion Boston, MA $153,600.00-$241,340.00 2 weeks ago
In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability. By joining our growing and dynamic regulatory affairs team, youll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. 8+ years of Regulatory Affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development both big and small company experience is preferred.. Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (e.g., orphan products, fast track, breakthrough therapies, PRIME).. Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs
Compensation : Base salary up to $220k, Plus Bonus, Plus LTI. Scientific Search has recently partnered with an innovative biopharmaceutical company who has tasked us in finding them a Director, Regulatory Affairs.. Support European development-stage regulatory activities, including contribution to CTA and MAA strategies and filings (execution will be led by regional team).. Bachelor’s degree in life sciences required; advanced degree (MS, PharmD, PhD, or equivalent) strongly preferred. Prior involvement in European regulatory strategy and filings (e.g., CTA, MAA) preferred
At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock.. Lead Correspondence with US Agencies (CVB-IC and FD-ORA). Maintain current registrations with the US Drug Enforcement Administration. Biological/Chemistry based degree: B.S. with 14 years, M.S. with 12 years, or DVM/Ph. D. with 9 years, with direct experience in biological or pharmaceutical science development or manufacture.. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock.
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.
The Regulatory Affairs Program Manager is responsible for a multitude of multi-year projects and programs leading mandatory and strategic regulatory change supporting multiple lines of business. Works closely with Regulatory Affairs Managers to ensure business unit account remediation projects meet regulatory expectations, have effective project plans, and provide regular reporting to Bank executives and the Board. The position reports to the Executive Director of Regulatory Affairs. Work closely with Regulatory Affairs Analyst and business unit subject matter experts and stakeholders to ensure remediation efforts are well planned and effectively executed. Assist Regulatory Affairs management regulatory change management functions to ensure the bank is managing effectively changing regulatory landscape.
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.
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.
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
Maintain regulatory files for each ingredient (TDS, SDS, Cof A, ingredient breakdown, Impurities profile etc. Support ISO and CGMP quality systems in coordination with global network of corporate regulatory and quality management.. BA/BS in Science; preferably Chemistry, Biochemistry or Microbiology. Health Savings Account (HSA) (for employees working 20+ hours per week). For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
This clinical-stage, neuromuscular biotech has a diversified pipeline of gene therapy programs across neuromuscular and cardiac diseases. We are looking for a Director of Regulatory Affairs with gene therapy experience to oversee all aspects of regulatory submissions (operations and strategy). This person will be working closely with the company's next-generation gene therapy programs. BS, Master's, PharmD, or PhD preferred. Previous gene therapy experience
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
Coordinating with CRA, ADD, FDD, MSTG, PMO, plant team, and other CFT members for regulatory requirements related to registration, re-registration, queries, and variation filing.. Active participation in the Product Life Cycle Management, including change control meetings, stakeholder discussions, and decision-making on variation categories (with concurrence from CRA, Country RA, and customers as needed).. Monitoring circulation of regulatory approvals and commitments, and providing approval packages for emerging markets.. Participating in launch discussions with plant CFT, business teams, and CRA to identify gaps and mitigation plans.. Monitoring product permissions, test licenses, and maintaining archival activities for local FDA compliance.
Ensure that nuclear facilities and operations are in full compliance with regulatory standards such as the Atomic Energy Act, the Code of Federal Regulations (CFR), and various industry-specific safety and environmental standards.. Work closely with senior leadership to integrate regulatory considerations into long-term business strategy, including nuclear plant construction, upgrades, or decommissioning.. Identify, assess, and mitigate regulatory risks related to the licensing, operation, and shutdown of nuclear plants.. Bachelor's degree (minimum), Master's or advanced degree preferred (e.g., Nuclear Engineering, Regulatory Affairs, Environmental Science, Law).. 15+ years in nuclear power industry, with 10+ years in regulatory affairs, including leadership experience in managing teams and projects, and specific regulatory experience with NRC or equivalent bodies.