Consultant, Regulatory Operations
On-siteBengaluru, Karnataka, India
Job Summary
Prepare, format, and quality check regulatory documents including clinical, nonclinical, CMC, and labelling materials to ensure submission readiness. Perform document-level activities such as PDF conversion, hyperlinking, bookmarking, and pagination checks while supporting compilation and publishing in eCTD format using approved tools. Assist in preparation of submissions for IND, NDA, ANDA, MAA, variations, renewals, and amendments, conducting technical validation checks and resolving errors under senior guidance. Coordinate with CMC Regulatory Affairs, Labelling, Clinical, and Quality teams to organize documents and track publishing activities, timelines, and validation status. Dispatch submissions through regional health authority gateways such as FDA ESG, EMA, and MHRA portals while maintaining audit-ready records. Follow ICH guidelines, regional eCTD specifications, and internal SOPs to ensure compliance across US, EU, UK, and Canadian markets.
Required Qualifications
- Bachelor's degree in life sciences, pharmacy, regulatory affairs, biotechnology, or a related discipline
- Minimum 2 years of relevant experience in regulatory publishing, regulatory operations, eCTD compilation, submission formatting, validation, or related pharmaceutical/biologics regulatory submission activities
- Hands-on experience in regulatory document preparation, PDF conversion, hyperlinking, bookmarking, pagination checks, file naming checks, document property verification and submission-readiness review
- Working knowledge of eCTD publishing activities, including sequence preparation, document placement, leaf title review, metadata checks, lifecycle operator checks and technical validation support
- Experience using publishing, validation and document management tools such as Lorenz DocuBridge, Lorenz e-validator, ISI Toolbox, Adobe Acrobat Pro, RIM systems or equivalent tools
- Basic understanding of ICH guidelines, regional eCTD specifications, health authority submission requirements, internal SOPs, quality checklists and document management practices
- Ability to support submission types such as IND, NDA, ANDA, MAA, variations, renewals, amendments, supplements and responses to health authority queries, as applicable
- Experience supporting technical validation checks and assisting in resolution of validation errors, warnings, document quality issues and publishing-related queries under guidance
- Good coordination skills with the ability to work with CMC Regulatory Affairs, Labelling, Clinical, Quality and other cross-functional teams for timely receipt and processing of submission documents
- Strong attention to detail, accuracy, timeline orientation and ability to maintain audit-ready publishing records, validation reports, acknowledgements and dispatch confirmations
- Good written and verbal communication skills with the ability to provide timely updates, escalate issues appropriately and work effectively under supervision in a deadline-driven environment
- Prior exposure to regulatory publishing activities for multiple regions such as US, EU, UK, Canada and other international markets
- Working familiarity with health authority gateway or portal submissions, including FDA ESG, EMA Gateway/Web Client, MHRA Submissions Portal, CESP or other regional submission portals
- Experience supporting lifecycle management submissions, including variations, renewals, amendments, supplements, annual reports and responses to health authority questions
- Familiarity with submission tracking, acknowledgement tracking, validation report archival, dispatch confirmation maintenance and audit-ready publishing documentation
- Basic knowledge of regulatory information management systems, document management systems and electronic submission archive practices
- Awareness of publishing quality control practices, including peer review checklists, technical document checks, folder structure verification and sequence readiness checks
- Ability to support process improvement, standardization, automation or digitization initiatives within Regulatory Operations
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