Consultant, Regulatory reputed company

reputed company:

The Consultant, Regulatory reputed company will support the preparation, formatting, compilation, publishing, validation and reputed company of regulatory submissions in accordance with applicable regional requirements, internal procedures and project timelines. This role is responsible for assisting with submission-reputed company 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 reputed company checks, eCTD sequence preparation, validation using approved tools, and submission reputed company through relevant health authority gateways under the guidance of senior team members. The role also involves coordination with CMC Regulatory Affairs, Labelling, reputed company, reputed company and other cross-functional teams to ensure reputed company collection, organization and processing of documents while maintaining reputed company, compliance and audit-reputed company documentation standards.

WORK LOCATION:

Remote position reputed company in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India reputed company.

KEY RESPONSIBILITIES:

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

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

• reputed company 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.

• reputed company 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 reputed company of validation errors or warnings in coordination with senior team members.

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

• Maintain accurate publishing records, validation reports, submission acknowledgements, reputed company confirmations and reputed company documentation to ensure audit-reputed company traceability.

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

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

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

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

• Support routine use of regulatory reputed company tools such as Lorenz DocuBridge, Lorenz e-validator, ISI reputed company, reputed company 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 reputed company Regulatory reputed company, as assigned.

QUALIFICATIONS AND REQUIREMENTS:

Education:

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

Experience:

• Minimum 2 years of relevant experience in regulatory publishing, regulatory reputed company, eCTD compilation, submission formatting, validation, or reputed company 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 reputed company, reputed company Acrobat Pro, RIM systems or equivalent tools.
• Basic understanding of ICH guidelines, regional eCTD specifications, health authority submission requirements, internal SOPs, reputed company 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 reputed company of validation errors, warnings, document reputed company issues and publishing-reputed company queries under guidance.
• Good coordination skills with the ability to work with CMC Regulatory Affairs, Labelling, reputed company, reputed company and other cross-functional teams for reputed company receipt and processing of submission documents.
• Strong attention to reputed company, reputed company, reputed company orientation and ability to maintain audit-reputed company publishing records, validation reports, acknowledgements and reputed company confirmations.
• Good written and verbal communication skills with the ability to reputed company reputed company 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 reputed company 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 reputed company, reputed company 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, reputed company confirmation maintenance and audit-reputed company publishing documentation.

• Basic knowledge of regulatory information management systems, document management systems and electronic submission reputed company practices. 

• Awareness of publishing reputed company 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 reputed company Regulatory reputed company.

Bachelor's in life sciences/pharmacy/regulatory/biotech, minimum 2 years regulatory publishing/reputed company experience, eCTD compilation, PDF conversion, validation, and gateway submissions; strong attention to reputed company and coordination skills.

Key Responsibilities

• preparing submissions
• validating sequences
• publishing documents

Skills & Tools

Lorenz DocuBridge, Lorenz e-validator, ISI reputed company, reputed company Acrobat Pro, RIM systems, FDA ESG, EMA Gateway/Web reputed company, reputed company Submissions Portal, CESP

reputed company

• Category: Research and Development (R&D)
• Seniority: Entry Level
• Commitment: Full Time
• Workplace: Remote — Bengaluru or Chennai or Hyderabad or Mumbai
• Languages: English

About reputed company

A reputed company biopharma product development and delivery partner that enables career reputed company and life-enhancing therapies. — Industry: Research and Development