Senior Publisher – Regulatory Submissions (eCTD) – Bengaluru/Chennai, India
Location: Bengaluru, Karnataka or Chennai, Tamil Nadu (Hybrid)
Department: Regulatory & Drug Development Consulting (RDC)
Position Type: Full-Time
Experience Required: 2+ Years (Submissions to US FDA, EMA, Health Canada preferred)
Openings: 1
Job Summary:
Allucent is seeking a Senior Publisher – Regulatory Submissions to join our global Regulatory & Drug Development Consulting team. The ideal candidate will have hands-on expertise in publishing electronic submissions (eCTD) across multiple global regulatory regions and will contribute significantly to internal knowledge-sharing, client engagement, and submission quality.
Key Responsibilities:
Prepare, compile, and publish regulatory submissions (eCTD and other formats) for investigational, new, and marketed products.
Manage timelines and ensure submission delivery in accordance with sponsor expectations and Health Authority deadlines.
Format and compile complex documents using tools such as DocuBridge, ISI Toolbox, and Microsoft Office Suite.
Mentor junior publishing staff and support their professional development.
Serve as SME in publishing processes, participate in SOP/QMS updates, and support software tool evaluations.
Liaise with cross-functional project teams and regulatory authorities to resolve technical and submission-related issues.
Support internal training sessions and client education on submission expectations and document requirements.
Provide input during bids and proposals and support client meetings, bid defenses, and audits.
Manage direct reports (if applicable), oversee team workload, and ensure project delivery efficiency.
Requirements:
Bachelor’s, Master’s, or PhD in Life Sciences or a related field.
2+ years of experience with eCTD publishing and regulatory submissions to US FDA, EMA, or Health Canada.
Proficient in publishing software (e.g., DocuBridge, ISI Toolbox), SharePoint, MS Word, Excel, PowerPoint.
Strong working knowledge of global regulatory submission standards and document lifecycle.
Excellent communication skills, time management, and multitasking capabilities.
RAC Certification (preferred).
Benefits:
Competitive salary and comprehensive benefits package.
Departmental training budget and access to technical/soft-skill platforms like GoodHabitz.
Flexible working hours and hybrid work model.
Internal career growth opportunities, mentoring, and Buddy Program.
Spot Bonus and Loyalty Award Programs.
Employee referral incentives.
Estimated Salary: ₹10 – ₹14 LPA (based on experience and skillset)
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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