Principal Regulatory Operations Publisher

Accountabilities: Independently lead regulatory publishing projects from planning through completion, ensuring timely and successful delivery. Manage the finalisation, formatting, quality control, and publishing of regulatory documents for electronic submissions. Coordinate with Medical Writing, Biostatistics, Programming, Regulatory Affairs, and other cross-functional teams to ensure submission readiness. Independently manage major regulatory dossiers and submission amendments of varying complexity and scope. Ensure regulatory documents comply with applicable publishing standards, technical requirements, and submission guidelines. Represent the Regulatory Operations function in critical business activities and cross-functional project discussions. Serve as a technical escalation point for regulatory publishing questions, troubleshooting, and complex document-related challenges. Mentor and support junior team members, sharing technical expertise and promoting best practices. Contribute to continuous improvement initiatives within regulatory publishing workflows and operational processes. Support global regulatory submissions, including FDA and EMA submissions, as well as post-marketing regulatory activities. Requirements: Bachelor’s degree, preferably in a scientific discipline. At least 8 years of relevant regulatory publishing experience within a contract research organisation (CRO), pharmaceutical company, biotechnology organisation, or clinical research setting. Advanced proficiency in Adobe Acrobat, ISIToolbox, and regulatory publishing software such as eCTDmanager, DocuBridge, or eCTDXpress. Strong expertise in Microsoft Word formatting, including advanced use of styles and templates, as well as familiarity with EndNote. Proven ability to independently manage complex regulatory publishing projects and lead project teams effectively. Experience with global regulatory submissions, including FDA and EMA requirements, is highly desirable. Familiarity with post-marketing submissions is preferred. Strong understanding of medical and statistical terminology. Excellent written and verbal English communication skills, including writing, editing, and document review. Exceptional attention to detail and commitment to accuracy, consistency, and regulatory compliance. Strong interpersonal, organisational, and stakeholder-management skills. Ability to work collaboratively across multidisciplinary teams and act as a consultative regulatory publishing partner. Demonstrated leadership, mentoring, and problem-solving capabilities. Benefits: Fully remote working opportunities, including eligibility for remote work from India. Competitive compensation, with salary determined according to location, skills, experience, education, and relevant market conditions. Performance-based bonus opportunities, where applicable. Flexible time-off arrangements. Paid holidays. Medical insurance, depending on location. Tuition reimbursement and professional development support, where available. Retirement plans, depending on regional eligibility. Opportunity to contribute to global clinical research programmes and support the development of life-changing therapies. Collaborative and inclusive international working environment. Career development opportunities within a specialised regulatory operations and clinical research setting.