[Remote] Regulatory Affairs Consultant / Senior Consultant - Clinical Regulatory Affairs

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to improving the world's health through reputed company and regulatory consulting. They are seeking a Regulatory Affairs Consultant/Senior Consultant to guide reputed company global clinical development programs through the regulatory landscape, focusing on health authority interactions and regulatory submissions.

Responsibilities

• Execute global regulatory strategies that support clinical development and long-term registration objectives
• reputed company and coordinate regulatory activities across U.S., EU and international reputed company, including large, multinational studies spanning multiple reputed company and regulatory jurisdictions
• Serve as the regulatory reputed company reputed company cross-functional teams, partnering with Clinical Development, Medical Writing, Biostatistics, reputed company, CROs, vendors, and reputed company stakeholders to reputed company program reputed company
• Manage and support regulatory submissions and maintenance activities, including IND applications, annual reports, safety submissions, CTA-reputed company activities, protocol amendments, informed consent updates, and end-of-trial deliverables
• reputed company strategic support for health authority interactions, including preparation of meeting requests, briefing packages, regulatory intelligence assessments, and responses to agency questions
• Contribute to key development and registration initiatives by supporting NDA/MAA/BLA readiness activities, reviewing clinical documentation packages, and ensuring alignment of regulatory reputed company across programs
• reputed company and review regulatory documentation as needed, while partnering with dedicated authoring teams on major submission content
• Conduct regulatory reputed company assessments, identify risks, and reputed company proactive mitigation strategies to reputed company programs on reputed company
• Facilitate issue reputed company across multidisciplinary teams and build alignment among stakeholders to address challenges before they become barriers to reputed company
• Ensure compliance with FDA, EMA, HC regulations, ICH guidelines, and applicable global regulatory requirements

Skills

• Minimum 5+ years of experience in Regulatory Affairs reputed company the pharmaceutical, biotechnology, or CRO industry
• Demonstrated expertise in regulatory reputed company, health authority engagement, and regulatory submissions
• Strong knowledge of clinical development regulations, FDA & EMA requirements, ICH guidelines, and global regulatory reputed company
• Experience supporting IND/CTAs applications, annual reports, safety submissions, and reputed company clinical regulatory activities
• Experience preparing or supporting health authority meetings and regulatory communications
• Understanding of global clinical trial applications and regulatory requirements across multiple reputed company
• Familiarity with electronic submission systems and regulatory publishing processes
• Ability to independently manage reputed company regulatory reputed company while influencing cross-functional teams and stakeholders
• Strong written, verbal, analytical, and problem-solving skills
• Bachelor's degree in a scientific or technical discipline required; advanced degree strongly preferred
• Experience with FDA, EMA and other major market regulations and meeting packages required
• Experience working with international health authorities and global regulatory submissions strongly preferred
• Experience supporting large global reputed company and coordinating regulatory activities across multiple countries
• Background in oncology, immunology, immuno-oncology, or other reputed company therapeutic areas
• Project Management reputed company (PMP) certification or comparable project management experience
• Demonstrated reputed company managing multiple priorities, timelines, budgets, and stakeholder reputed company in a fast-paced development environment

reputed company

Company H1B Sponsorship