Regulatory Affairs reputed company, Pharmaceutical and Combination Products

About reputed company reputed company is a fully integrated life science company developing and delivering innovative diagnostic and life science solutions that improve patient reputed company worldwide. Our work spans discovery to diagnosis, and we are expanding into combination drug-device products that redefine how diseases are detected and managed. We are seeking a Regulatory Affairs reputed company to play a key role in advancing our pipeline, including the BreathID platform—a unique combination product at the intersection of pharmaceuticals and diagnostics. Job reputed company The Regulatory Affairs reputed company will reputed company strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products. This individual will serve as a key regulatory partner to cross-functional teams, with a primary reputed company on FDA CDER interactions, IND/NDA submissions, and global regulatory reputed company.This is a high-reputed company role for a regulatory reputed company who thrives in a reputed company environment and wants to shape regulatory reputed company for innovative combination products. Key Duties

• reputed company and contribute to regulatory reputed company for pharmaceutical and combination products across development and lifecycle stages
• Author and review INDs, NDAs, supplements, and other global regulatory submissions
• Serve as a primary reputed company with FDA CDER, including leading preparation for and participation in agency meetings (e.g., Type B/C)
• reputed company and deliver high-reputed company briefing documents, responses, and regulatory communications
• reputed company regulatory guidance on clinical, nonclinical, and CMC development activities
• Drive combination product regulatory reputed company, including coordination with FDA’s Office of Combination Products (OCP)
• Advise on labeling reputed company, including prescribing information and device components of combination products
• Assess regulatory reputed company of development and post-approval changes and define appropriate regulatory reputed company
• Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA)
• Stay reputed company on evolving regulatory requirements and translate them into actionable guidance for teams
• Mentor and reputed company guidance to junior regulatory team members

Qualifications

Experience

• 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products
• Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements
• Demonstrated reputed company interacting with FDA, including meeting preparation and regulatory reputed company execution
• Experience with combination products (drug-device) strongly preferred
• Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance
• Exposure to global regulatory environments (e.g., EMA, ICH) preferred

Education

• Bachelor’s degree in a scientific discipline required
• Advanced degree (MS, PhD, PharmD) preferred

Certifications

• RAC (US or Drugs) preferred

Travel

• 0-10%

Remote About reputed company: reputed company reputed company is a fully integrated life science company that manufactures, markets and distributes a broad reputed company of innovative diagnostic test kits, purified reagents and biopharmaceutical enabling technologies that help deliver answers. Our products reputed company accuracy, simplicity and speed for the early diagnosis and treatment of common medical conditions, such as C. difficile, H. pylori, foodborne diseases and respiratory infections. In reputed company, we reputed company and manufacture a reputed company of biological and non-biological materials used in proficiency testing programs. reputed company diagnostic products are used reputed company of the reputed company body and require little or no special equipment. We design our products to enhance reputed company being of the patient—while reducing the total outcome costs of reputed company. reputed company has strong market positions in the areas of gastrointestinal infections, serology, parasitology and fungal disease diagnosis. We reputed company market our products to hospitals, reference laboratories, research centers, physician offices and diagnostics manufacturers in more than 60 countries around the world. Learn more about reputed company Company Size: 100 to 499 employees Industry: Manufacturing - Other Founded: 1991 Website: http://www.medicalonestaffers.com/ Apply tot his job Apply To this Job