Navatio Pharma Solutions is a global contract research organization (CRO) specializing in pharmacovigilance, materiovigilance, medical writing, regulatory affairs, and QPPV services. The company…
Navatio Pharma Solutions is a global contract research organization (CRO) specializing in pharmacovigilance, materiovigilance, medical writing, regulatory affairs, and QPPV services. The company…
We are seeking an experienced
Regulatory Operations & Publishing Specialist
with a strong background in
ophthalmic
to join our Regulatory Affairs team at our Hyderabad office. This role is fully in-house and will support global regulatory submissions by managing publishing, document lifecycle, and regulatory operations activities across multiple regions.
Key Responsibilities
Required Qualifications & Experience
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
4–6 years of hands-on experience
in Regulatory Operations and Publishing.
Proven experience in
ophthalmic products
(drugs, biologics, or combination products).
Strong working knowledge of
eCTD publishing tools
(e.g., Pharmaready, Lorenz, Extedo, DocuBridge, or equivalent).
Preferred Skills
Experience working in a fully in-house regulatory environment.
Familiarity with regulatory information management systems (RIMS).
Strong communication and cross-functional collaboration skills.
Ability to work independently and meet tight regulatory deadlines.
Startup jobs. A lot of them.
Your next opportunity is in here somewhere. Sign up to explore 52,000+ startups and their open roles. No spam. No gamification. Just jobs.
52,000+
Startups
66,000+
Open Roles
1,300+
New This Week
Software Engineer
Full-timeAustin, US
Full-time • Austin, US
Machine Learning Engineer
Full-timeLondon, GB
Full-time • London, GB
AI Researcher
Full-timeManchester, GB
Full-time • Manchester, GB
Data Scientist
InternshipJerusalem
Internship • Jerusalem
Mobile Developer
InternshipLondon, GB
Internship • London, GB
Machine Learning Engineer
Full-timeHaifa
Full-time • Haifa
Manage end-to-end
regulatory publishing activities
for global submissions (eCTD and non-eCTD).
Compile, format, validate, and publish regulatory submissions, responses, and amendments in compliance with regional requirements (US FDA, EMA, MHRA, and other global agencies).
Support
regulatory operations
including document management, submission tracking, and archiving.
Maintain regulatory databases, submission timelines, and health authority correspondence.
Ensure documents comply with
ICH, regional regulatory guidelines
, and internal SOPs.
Perform quality checks on submission-ready documents (hyperlinking, bookmarking, granularity, and validation).
Collaborate closely with Regulatory Affairs, Medical Writing, Quality, and other cross-functional teams.
Manage submission lifecycle activities including publishing, dispatch, lifecycle management, and post-submission updates.
Support audits and inspections by ensuring regulatory documentation readiness.
Experience with global regulatory submissions (IND, NDA, BLA, MAA, variations, responses).
Solid understanding of regulatory guidelines (FDA, EMA, ICH).
Excellent attention to detail, organizational skills, and ability to manage multiple submissions simultaneously.
