Regulatory Affairs Jobs

Why should you join dLocal? dLocal enables the biggest companies in the world to collect payments in 40 countries in emerging markets. Global brands rely on us to increase conversion rates and simplify payment expansion effortlessly. As both a payments processor and a merchant of record where we ope

Join the Mitsubishi Motors North America (MMNA) Team! At Mitsubishi Motors NA, we are driving innovation, quality, and excellence in the automotive industry. Our commitment to delivering cutting-edge vehicles goes hand in hand with our dedication to fostering a dynamic and inclusive wor

Position Summary: Are you a mission-driven attorney with a passion for administrative law and regulatory advocacy? Do you want to research and analyze cutting-edge statutory, administrative, and constitutional issues? If so, Democracy Forward Foundation ("Democracy Forward") is looking for a Staff A

Lead regulatory activities for filing INDs, CTAs, and maintenance activities for open applications, including DSURs, IND/CTA amendments, and responses to requests for information/queries. Work effectively and collaboratively with internal and external stakeholders to manage clinical regulatory activ

Noema Pharma is a biotech company developing groundbreaking therapies to address the most disabling symptoms in orphan conditions of the brain and nervous system. Noema’s research and development is focused on understanding and meeting patient needs using our novel therapies. Tasks The Director of R

Overview Who We Are: At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight

COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapie

Note: APA operates on a 37.5-hour work week with one-hour lunch breaks each day. APA sets salaries based on several considerations, including years of relevant experience, level of education, and previous staff and/or governance experience at APA. The Health Policy and Healthcare Financing Departmen

Job Title: Manager of Regulatory Affairs Job Type: Full-Time (Remote) ARMRA Schedule: Monday-Friday, 9 am - 6 pm EST About ARMRA: ARMRA® was born from a near-fatal health crisis that forced its Founder & CEO, Dr. Sarah Rahal, to uncover what modern life has stolen. As a pediatric neu

We are seeking a highly experienced and strategically driven Associate Director of Regulatory Affairs to lead and support the development and execution of global regulatory strategies across complex development programs. This role offers an excellent opportunity for a regulatory professional with st

Job Description Act as accountable owner for CTD Modules 2.3.S, 2.3.P, 3.2.S, and 3.2.P. Govern review and approval of formulation, QC, and manufacturing CTD content. Define dossier-level regulatory strategy for assigned global markets. Ensure consistency across DMF linkage, stability data, and qual

ABOUT HOUSING CALIFORNIA Since 1988, Housing California (Housing CA) has worked to create a California with homes, health, and prosperity for all in thriving, sustainable communities. We bring together a diverse, cross-sector network to prevent and end homelessness, increase the supply of safe, stab

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective

The position is primarily responsible for handling Regulatory related matters and executing licensing, permits, and product registration activities of assigned Business Partner with the end goal of having internal processes that consistently comply with all regulatory standards. Ensure over all comp

About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of c

Job Description Independently compile, review, and finalize complete regulatory dossiers in country-specific formats for Central American markets in compliance with RTCA regulations. Perform detailed line-by-line review of all dossier components including administrative, quality, and labeling docume

The Director, Global Regulatory Affairs will play a critical role in developing and implementing regulatory strategies to support the global development and expansion of Janux’s clinical pipeline. This player-coach individual will work closely with cross-functional teams to ensure compliance with re

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

About Loyal Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging

WHO ARE WE? We are the VMS Co-Op, a group of fast growing companies in the Vitamins, Minerals and Supplements (VMS) space. The VMS Co-Op includes OLLY, SmartyPants. This position's home company is OLLY.​ THE ROLE: VP QA/RA The Vice President of Quality Assurance & Regulato