MLR Submission Specialist – Senior Executive

Omnicom Global Solutions; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Omnicom Global Solutions seeks a Senior Executive – Submission Specialist to format, review, and organize regulatory documents for global submissions, ensuring compliance with FDA/EMA/ICH standards and maintaining version control.

You will manage document workflows in Veeva Vault PromoMats, perform QC, hyperlinking, and metadata tagging, and support regulatory leads through final review and validation to ensure submission readiness.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biochemistry, or related field.
• 6–8 years of experience in regulatory document management, scientific content formatting, or quality control within a healthcare setting.
• Strong understanding of global regulatory standards (FDA, EMA, ICH) and experience with submission platforms like Veeva Vault.
• Excellent document formatting skills and familiarity with QC processes.
• Strong organizational habits and an eye for compliance, structure, and detail.
• Strong document formatting and QC expertise in Microsoft Word and Adobe Acrobat.
• Meticulous attention to detail with a commitment to compliance.
• Ability to coordinate submission schedules and manage multiple timelines.

Responsibilities

• Prepare, format, and review regulatory and scientific documents for submissions, including dossiers, reports, brochures, and promotional materials.
• Perform advanced QC, hyperlinking, cross-referencing, and metadata tagging across documents.
• Ensure adherence to submission standards (FDA, EMA, brand-specific templates, and style guides).
• Collaborate with cross-functional stakeholders to track submission timelines and resolve formatting issues.
• Manage asset uploads, linking, annotation, and audit trails within systems such as Veeva PromoMats.
• Maintain organized documentation systems including version histories, templates, reference binders, and trackers.
• Formatting and validating documents for submission readiness as per health authority and client guidelines.
• Hyperlinking sections and references for ease of navigation in submission packages.
• Running QC checks and resolving formatting errors and inconsistencies.
• Managing document workflows, trackers, and master files across multiple submissions.
• Uploading assets and tagging content in platforms like Veeva Vault, while maintaining metadata and submission records.
• Supporting publishing and regulatory leads during final review and validation.

Skills

Regulatory document management

Document formatting

Quality control

Cross-functional collaboration

Metadata tagging

Version control

Veeva Vault

Education

Bachelor's degree in Life Sciences/related field

Tools

Veeva Vault PromoMats

Documentum

Microsoft Word

Adobe Acrobat

Job description

Omnicom Global Solutions (OGS) is an integral part of Omnicom Group, a leading global marketing and corporate communications company. Omnicom’s branded networks and specialty firms deliver advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations, and other specialized communication solutions to over 5,000 clients across more than 70 countries.

OGS India serves as a key global capability center for Omnicom, enabling its agencies and group companies with scaled delivery, specialized expertise, and integrated solutions. Our capabilities span Media, Data & Analytics, Technology, MarTech, Commerce, Business Support Solutions, Creative Production, Healthcare, and Strategy & Insights.

With a workforce of over 7,000 professionals in India, OGS continues to expand its capabilities and global impact, supporting the evolving needs of clients and agencies. We are committed to building future-ready talent and delivering high-quality, outcome-driven solutions.

OGS India continues to expand its scale and capabilities through the integration of additional global operations, further strengthening its position as a strategic solutions engine for Omnicom.

Let’s build what’s next.

Omnicom Health

At Omnicom Health, you’re not just starting a job—you’re becoming part of something bigger. As one of the largest and most specialized global healthcare networks, we’re dedicated to building the ideas and solutions of tomorrow.

Your career here is about growth, impact, and the chance to shape the future of healthcare. Every day, the work you do will contribute to a greater cause, making a real difference in people’s lives.

The OGS-OH partnership empowers some of the world’s iconic brands with Knowledge, Innovation, and Transformation. When you join, you become part of a dynamic team that delivers high-impact solutions in the healthcare marketing and communications space.

About Our Agency Wildtype

We are Wildtype. An agency of a different stripe. Wildtype runs like no other. As the most agile full-service agency in healthcare, we aren’t beholden to ritual. Powered by diverse ideas, knowledge, and people, our unique creative process is a force of nature, removing obstacles between brand and growth in wild new ways.

Know more at: https://wildtypehealth.com/

JOB SUMMARY:

As a Senior Executive – Submission Specialist, you will be responsible for formatting, reviewing, and organizing scientific, promotional, and regulatory documents to meet submission requirements. You will ensure compliance with global standards, manage document workflows, perform quality checks, and maintain version control. This role is critical in supporting regulatory timelines and upholding documentation excellence for agency and client submissions.

ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES:

• Prepare, compile, and format regulatory and scientific documents for submissions, including dossiers, reports, brochures, and promotional materials.
• Perform advanced QC, hyperlinking, cross-referencing, and metadata tagging across documents.
• Ensure adherence to submission standards (FDA, EMA, brand-specific templates, and style guides).
• Collaborate with cross-functional stakeholders to track submission timelines and resolve formatting issues.
• Manage asset uploads, linking, annotation, and audit trails within systems such as Veeva PromoMats.
• Maintain organized documentation systems including version histories, templates, reference binders, and trackers.
• Formatting and validating documents for submission readiness as per health authority and client guidelines.
• Hyperlinking sections and references for ease of navigation in submission packages.
• Running QC checks and resolving formatting errors and inconsistencies.
• Managing document workflows, trackers, and master files across multiple submissions.
• Uploading assets and tagging content in platforms like Veeva Vault, while maintaining metadata and submission records.
• Supporting publishing and regulatory leads during final review and validation.

This may be the right role for you if you have:

• A Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biochemistry, or a related field.
• 6–8 years of experience in regulatory document management, scientific content formatting, or quality control within a healthcare setting.
• Strong understanding of global regulatory standards (FDA, EMA, ICH) and experience with submission platforms like Veeva Vault.
• Excellent document formatting skills and familiarity with QC processes.
• Strong organizational habits and an eye for compliance, structure, and detail.
• Strong document formatting and QC expertise in Microsoft Word and Adobe Acrobat.
• Meticulous attention to detail with a commitment to compliance.
• Ability to coordinate submission schedules and manage multiple timelines.
• Proactive communication and collaboration with writers, editors, and regulatory partners.
• Familiarity with global submission standards and documentation tools.
• Structured and organized with excellent content tracking and version control practices.

Good to Have:

• Hands-on experience with end-to-end Veeva submission workflows
• Exposure to multiple asset types (digital, print, email)
• Understanding of MLR review comments and resolution workflows
• Experience working with global brands or US markets

Basic stakeholder communication exposure

• Editing & Document Control: Microsoft Word (Advanced Formatting), Adobe Acrobat Pro
• Regulatory Platforms: Veeva Vault PromoMats, Documentum
• Optional Tools: Submission Trackers, Content Management Templates
• Preferred Certifications: Regulatory Submission (DIA), Basics of Regulatory Affairs (RAPS), eCTD or Veeva Platform Certificate