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R&D Ancillary Document Coordinator

4-10 years
Not Disclosed
10 June 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

R&D Ancillary Document Coordinator

 

Location: Hyderabad, India
Company: Sanofi
Job Type: Full-time | Permanent
Work Mode: On-site
Experience Level: Mid to Senior Level
Salary Range: Not specified


Job Summary

Sanofi is hiring an R&D Ancillary Document Coordinator in Hyderabad to support global regulatory submissions. This pivotal role involves planning, tracking, and managing ancillary documentation across markets in coordination with regulatory teams, vendors, and stakeholders. Ideal for professionals with a strong regulatory operations background and experience using systems like Vault RIM, this position contributes directly to high-quality health authority submissions.


Key Responsibilities

  • Plan, track, and coordinate ancillary documents for regulatory submissions

  • Act as subject matter expert (SME) for regional documentation requirements

  • Liaise with stakeholders and vendors to ensure timely request and shipment of documents

  • Draft and review Certificate of Pharmaceutical Product (CPP) forms and templates

  • Maintain ancillary document tracking tools and systems

  • Upload, manage, and complete metadata for documents in Vault RIM

  • Support process enhancements and new technology implementation in coordination with digital teams

  • Provide regulatory guidance and ensure compliance with country-specific requirements

  • Ensure high-quality document submission aligned with health authority standards


Required Skills & Qualifications

  • Bachelor's degree or equivalent in Regulatory Affairs, Sciences, or related field

  • Experience in regulatory operations within the pharmaceutical industry

  • Proficient in Vault RIM and regulatory information management systems

  • Strong understanding of regional and global submission standards

  • Expertise in MS Office and Adobe Acrobat

  • Ability to manage cross-functional communications and prioritize tasks

  • Self-motivated, detail-oriented, and adaptable to new technologies

  • Strong verbal and written English communication skills

  • Knowledge of dossier structures and production processes


Perks & Benefits

  • Be part of a global leader in pharmaceutical innovation

  • Diverse career growth opportunities with international mobility

  • Inclusive and future-focused workplace culture

  • Competitive rewards package with wellness and parental leave benefits

  • Opportunity to shape regulatory excellence and global healthcare access


Company Description

Sanofi is a leading global healthcare company dedicated to discovering and delivering innovative treatments that improve lives. With a strong focus on regulatory science, biopharma innovation, and global health, Sanofi empowers employees to drive progress in healthcare through collaboration and expertise.


Work Mode

On-site – Hyderabad, India


Call to Action

Are you ready to contribute to global regulatory excellence? Join Sanofi and help bring lifesaving therapies to patients worldwide. Apply now and build your future with one of the most respected names in global healthcare.