Job Summary
Syneos Health is seeking a skilled and experienced Lead – Regulatory Writing professional for its Bangalore office. The ideal candidate will possess 4 to 6 years of hands-on experience in authoring and reviewing a variety of clinical and regulatory documents supporting global filings, including CTD Modules 2 and 5. This leadership role involves coordinating cross-functional teams, developing regulatory submissions, and mentoring junior writers, ensuring alignment with international guidelines and best practices.
Key Responsibilities
Prepare and review clinical and regulatory documents including CSRs, protocols, IBs, and submission data summaries.
Apply lean authoring principles and structured content management to document development.
Develop, coordinate, and monitor project plans ensuring adherence to timelines and quality.
Lead document review meetings, address stakeholder feedback, and ensure consensus.
Train and mentor junior writing staff on processes, templates, and tools.
Conduct literature searches and stay current with regulatory guidelines and industry standards.
Collaborate with cross-functional teams to ensure document content consistency and alignment with strategies.
Manage document workflows, approvals, and version control using document management systems.
Required Skills & Qualifications
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
4 to 6 years of experience in regulatory and clinical writing for CTD Module 2 and 5
Expertise in authoring CSRs, protocols, IBs, amendments, and CTD summaries
Strong understanding of global regulatory guidelines (EU, US)
Proficiency in MS Word and document management tools
Strong analytical, communication, and leadership skills
Ability to lead cross-functional teams and manage complex document projects
Familiarity with lean authoring and structured content libraries
Capability to mentor junior writers and ensure adherence to best practices
Perks & Benefits
Opportunity to lead global regulatory writing projects
Career advancement and development programs
Exposure to cutting-edge therapies and clinical research
Collaborative and inclusive work environment
Comprehensive Total Rewards Program
Company Description
Syneos Health is a globally recognized biopharmaceutical solutions organization specializing in clinical development, regulatory affairs, and medical writing. We partner with top pharma companies to accelerate life-changing therapies through innovative and compliant regulatory strategies.
Work Mode
On-site – Bangalore, Karnataka, India
Call to Action
Are you ready to lead regulatory writing projects that impact global healthcare? Apply today to join Syneos Health and shape the future of medical innovation!
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Siliguri |Illinois :
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Canada |Quebec :
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Brussels |Antwerp :
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Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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