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.