Consultant, Regulatory Operations

POSITION OVERVIEW:

The Consultant, Regulatory Operations will support the preparation, formatting, compilation, publishing, validation and dispatch of regulatory submissions in accordance with applicable regional requirements, internal procedures and project timelines. This role is responsible for assisting with submission-ready document preparation, eCTD publishing activities, technical validation checks and lifecycle submission support for dossiers such as IND, NDA, ANDA, MAA, variations, renewals, amendments and responses, as applicable.

The position requires hands-on support in regulatory document conversion, hyperlinking, bookmarking, PDF quality checks, eCTD sequence preparation, validation using approved tools, and submission dispatch through relevant health authority gateways under the guidance of senior team members. The role also involves coordination with CMC Regulatory Affairs, Labelling, Clinical, Quality and other cross-functional teams to ensure timely collection, organization and processing of documents while maintaining accuracy, compliance and audit-ready documentation standards.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Prepare, convert, format and quality check regulatory documents, including clinical, nonclinical, CMC, labelling and administrative documents, to ensure they are submission-ready and compliant with applicable formatting standards.

• Perform document-level activities such as PDF conversion, hyperlinking, bookmarking, pagination checks, document property verification, file naming checks and technical readiness review as per internal procedures and submission requirements. 

• Support compilation and publishing of assigned regulatory submissions in eCTD format using approved publishing tools under the guidance of senior team members.

• Assist in preparation of regulatory submissions including IND, NDA, ANDA, MAA, variations, renewals, amendments, supplements and responses to health authority queries, as applicable.

• Perform eCTD sequence preparation, document placement, leaf title checks, metadata review and lifecycle operator checks in accordance with regional regulatory requirements and internal checklists.

• Conduct technical validation of assigned submissions using approved validation tools and support resolution of validation errors or warnings in coordination with senior team members.

• Support dispatch of submissions through applicable health authority gateways or portals such as FDA ESG, EMA Gateway/Web Client, MHRA Submissions Portal and other regional systems, as required. 

• Maintain accurate publishing records, validation reports, submission acknowledgements, dispatch confirmations and related documentation to ensure audit-ready traceability.

• Coordinate with CMC Regulatory Affairs, Labelling, Clinical, Quality and other cross-functional teams for timely receipt, review, organization and processing of documents required for regulatory submissions.

• Track assigned publishing activities, timelines, pending documents, validation status and submission milestones, and provide timely updates to senior team members and stakeholders.

• Follow applicable ICH guidelines, regional eCTD specifications, internal SOPs, work instructions, naming conventions, quality checklists and document management requirements while performing assigned activities.

• Escalate document quality issues, publishing challenges, validation errors, missing inputs, timeline risks or technical system issues in a timely manner to ensure submission continuity and compliance.

• Support routine use of regulatory operations tools such as Lorenz DocuBridge, Lorenz e-validator, ISI Toolbox, Adobe Acrobat Pro, RIM systems and document management systems for assigned activities.

• Contribute to process improvement initiatives, standardization of publishing practices, checklist updates and digitization activities within Regulatory Operations, as assigned.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, biotechnology, or a related discipline.

Experience:

• 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.

Skills and Attributes:

• 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.