Principal Regulatory Publishing Specialist (Remote – India)
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Role Overview
Thepharmadaily.com presents an excellent opportunity for an experienced Principal Regulatory Publishing Specialist to join a leading global contract research organization. This role plays a critical part in regulatory publishing, electronic submissions, and ensuring the delivery of high-quality regulatory documentation for global clients. The position supports end-to-end submission preparation and contributes to successful regulatory review outcomes across multiple product milestones.
Position Summary
The Principal Regulatory Publishing Specialist ensures timely delivery of compliant electronic submissions and oversees the regulatory publishing process for assigned projects. The role includes quality review responsibilities, stakeholder coordination, project oversight, and mentoring publishing team members to maintain high scientific and regulatory standards.
Key Responsibilities
Prepare components of complex electronic regulatory submissions in alignment with global regulatory requirements and electronic document standards.
Assist in managing regulatory publishing and submission projects, ensuring timely and compliant deliverables.
Act as the primary point of contact for internal and external stakeholders on assigned studies.
Provide leadership, training, and mentoring to regulatory publishing personnel as required.
Assess sponsor needs and collaborate with project teams to produce high-quality, compliant submissions.
Conduct thorough quality reviews on documents prepared internally or externally to ensure alignment with client expectations and regulatory standards.
Support continuous process improvement initiatives in publishing systems and workflows.
Experience Required
Minimum 8+ years of relevant regulatory publishing or regulatory operations experience in the pharmaceutical, biotechnology, or CRO industry.
Experience handling complex electronic submissions, eCTD publishing, document formatting, and electronic document management systems.
Leadership or mentoring experience preferred.
Education
Bachelor’s degree in a scientific, technical, or related discipline.
Equivalent combinations of education, training, and experience may be considered.
Skills and Competencies
Strong leadership abilities with experience supervising, evaluating, and mentoring team members.
Proficiency in document management, electronic submissions, document publishing tools, and eCTD validation and viewing platforms.
Advanced knowledge of Microsoft Word, Microsoft Excel, Adobe Acrobat, XML, document templates, and troubleshooting formatting issues.
Strong analytical, organizational, and interpersonal skills to manage multiple complex projects simultaneously.
Ability to independently understand sponsor requirements and deliver compliant, high-quality submissions.
Excellent editorial and proofreading skills to ensure accuracy and consistency in regulatory documents.
Ability to adopt and learn new technologies independently.
Strong delegation, task management, and project oversight capabilities.
Why This Role is Important
This position is integral to advancing global regulatory submissions and ensuring the delivery of high-quality, compliant documentation critical to clinical development. You will work in a collaborative, technology-driven environment supporting innovative therapeutics and scientific programs worldwide.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Zaventem |South America :
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Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Manila |Croatia :
Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Buenos Aires |Republic of Egypt :
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Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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