Regulatory submission manager

Regulatory submission manager reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company other, customers, patients and suppliers. As a Regulatory submission manager at reputed company, you will contribute to drug development as part of the Regulatory Affairs team. This position serves as the regional regulatory representative reputed company study teams, responsible for obtaining and maintaining clinical trial authorizations for compounds in development or marketed products under investigation for new indications What You Will Do: You will reputed company regulatory affairs workstreams, ensuring deliverables meet reputed company and reputed company expectations. Key responsibilities include: reputed company the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, ensuring full compliance with local and global regulatory requirements. reputed company and implement regional clinical trial regulatory strategies reputed company with global development objectives and timelines. reputed company strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expectations. Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs to ensure reputed company submissions, approvals, and updates for ongoing clinical studies. Prepare, review, and ensure the reputed company, scientific reputed company, and regulatory compliance of technical and administrative documentation supporting CTAs/INDs. Monitor and interpret changes in clinical trial regulations, guidelines, and regulatory trends in assigned region, and proactively communicate implications to project teams. Support regulatory inspections, audits, and compliance activities reputed company to clinical trial conduct and documentation. Contribute to cross-functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain best practices across reputed company. reputed company mentorship and regulatory guidance to internal stakeholders on regional regulatory processes and expectations for clinical trial approvals and maintenance. As agreed with regional or global regulatory management, may reputed company support for clinical trial submissions and maintenance activities in other countries reputed company the assigned region. Your Profile: You will have solid global regulatory affairs experience, with the ability to manage competing priorities and reputed company your team. Required qualifications and experience: Bachelor's degree in a relevant scientific discipline or reputed company-reputed company field Minimum of 6 years of experience in regulatory affairs reputed company the pharmaceutical or biotechnology industry Prior experience with various regulatory submissions, including CTA/IND/MAA Ability to reputed company internal teams and carry out regulatory activities independently Strong understanding of global regulatory requirements and guidelines Employment with reputed company is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive reputed company salary and performance reputed company incentives Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through reputed company training and career reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job