Principal Regulatory Operations Publisher

Jobgether; India; Remote; INR 1,800,000 - 3,000,000; Full time

Benefits offered by this job

Fully remote work from India

Competitive compensation based on role

Performance-based bonus opportunities

Flexible time-off

Paid holidays

Medical insurance (location dependent)

Tuition reimbursement & professional发展

Job summary

Jobgether is seeking a Principal Regulatory Operations Publisher based in India to lead complex regulatory publishing projects and ensure the preparation and finalisation of electronic submissions. You will mentor peers, guide teams, and collaborate with Medical Writing, Biostatistics, Programming, and Regulatory Affairs to deliver compliant documentation on a global scale.

The role emphasizes independence, technical expertise, and leadership within a global clinical research setting, with fully

Qualifications

• Bachelor's degree in a scientific discipline.
• 8+ years of regulatory publishing experience in CRO/pharma/clinical research.
• Advanced proficiency with Adobe Acrobat and regulatory publishing tools.
• Strong MS Word formatting, styles/templates, and EndNote familiarity.
• Proven ability to independently manage complex publishing projects and teams.
• Experience with FDA/EMA submissions and global regulatory requirements.
• Post-marketing submissions familiarity preferred.
• Excellent English written and spoken communication; high attention to detail.

Responsibilities

• Lead regulatory publishing projects from planning to completion, ensuring timely delivery.
• Finalize, format, QC, and publish documents for electronic submissions.
• Coordinate with Medical Writing, Biostatistics, Programming, Regulatory Affairs and cross-functional teams.
• Manage major regulatory dossiers and submission amendments of varying complexity.
• Ensure documents comply with publishing standards and submission guidelines.
• Represent Regulatory Operations in cross-functional activities and discussions.
• Mentor junior team members and share best practices.
• Drive continuous improvement in publishing workflows and processes.
• Support FDA/EMA submissions and post-marketing activities.
• Collaborate with global teams to ensure submission readiness.

Skills

Regulatory publishing leadership

Stakeholder management

Technical mentoring

Attention to detail

Education

Bachelor's degree in science

Tools

Adobe Acrobat

ISIToolbox

eCTDmanager

DocuBridge

eCTDXpress

EndNote

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Regulatory Operations Publisher based in India.

Take on a senior-level role within a global clinical research and regulatory environment, helping accelerate the development and approval of life-changing therapies. As a Principal Regulatory Operations Publisher, you will independently lead complex regulatory publishing projects and ensure the successful preparation and finalisation of electronic regulatory submissions. You will collaborate closely with Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams to deliver high-quality, compliant documentation. Beyond project execution, you will provide technical guidance, mentor colleagues, and serve as a trusted expert for regulatory publishing challenges. This opportunity offers the chance to contribute to impactful clinical research programmes across therapeutic areas, including oncology and rare diseases. Join a collaborative, international team that values expertise, innovation, and flexible working arrangements.

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.