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Regulatory Consultant/Sr. Consultant - Rim/Veeva Business Analyst (Us Timeshift)

8+ years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Regulatory Consultant / Senior Consultant – RIM / Veeva Business Analyst (US Time Shift)

Location: Gurugram, India (Hybrid)
Job ID: 25104034
Updated: Yesterday
Organization: Syneos Health

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization supporting clients across clinical development, medical affairs, and commercial execution. With operations in more than 110 countries and a workforce of over 29,000 professionals, the company blends scientific, operational, and technology expertise to accelerate the delivery of life-changing therapies.

Syneos Health’s Clinical Development model places both the patient and customer at the center. The organization continually works to simplify processes, streamline operations, and improve the experience for clients and employees. The company culture is built on growth, learning, diversity of thought, and continuous improvement.

Position Overview

The Regulatory Consultant / Senior Consultant – RIM/Veeva Business Analyst will support regulatory technology enablement, process optimization, and system governance for global regulatory operations teams. This position requires strong analytical capabilities, excellent communication skills, and hands-on experience in RIM systems, especially Veeva. The role operates in US EST time shift to support global stakeholders.

Key Responsibilities

General Responsibilities

  • Provide system and process leadership with strong expertise in RIM and Veeva platforms.

  • Communicate effectively with cross-functional teams and global stakeholders.

  • Participate in requirement gathering, validation, and user acceptance testing (UAT).

  • Collaborate with Regulatory Operations, IT, and Process Development teams.

  • Ensure alignment between business needs and technology capabilities.

  • Work during EST time zone hours to support US-based teams.

Core Responsibilities

  • Act as the primary liaison between Regulatory Operations and IT/Tool Management groups.

  • Support technology enablement, business process evolution, and system optimization.

  • Gather, document, and maintain user requirements across regulatory functions.

  • Collaborate with Digital Technology Enablement (DTE) and Validation teams.

  • Lead or support UAT activities, including test script creation and oversight.

  • Serve as a Subject Matter Expert (SME) for RIM solutions and system capabilities.

  • Conduct user training, communication, and support for regulatory business tools.

  • Coordinate global regulatory data inputs, validate data gaps, and ensure workflow accuracy.

  • Oversee system enhancements in partnership with IT and process development teams.

  • Contribute to continuous improvement initiatives within the regulatory technology landscape.

Required Qualifications & Experience

  • Master’s degree in Life Sciences, Pharmacy, IT, Engineering, or related discipline.

  • Minimum 8+ years of overall professional experience.

  • Significant hands-on experience with RIM systems and Veeva Vault RIM is essential.

  • Proven experience in system requirement gathering, business analysis, validation, and UAT.

  • Strong stakeholder management and communication skills.

  • Ability to collaborate across regulatory, technical, and operational functions.

  • Experience supporting system enhancements, data validation, and process modernization.

  • Candidates with experience limited to regulatory publishing/submissions should not apply.

  • Availability to work in US EST time shift is mandatory.

Preferred Skills

  • Experience working in global biopharmaceutical or CRO organizations.

  • Ability to document business needs clearly and translate them into technical specifications.

  • Strong analytical, problem-solving, and decision-making abilities.

  • Proactive and detail-oriented mindset with the ability to work under tight deadlines.

Why Join Syneos Health

  • Structured career development and continuous learning opportunities.

  • Supportive leadership and a collaborative work culture.

  • Access to global teams, expertise, and advanced technology platforms.

  • Commitment to diversity, inclusion, authenticity, and employee well-being.

  • Total Rewards program including recognition, benefits, and professional growth pathways.

Impact and Global Reach

Over the past five years, Syneos Health has supported:

  • 94 percent of all FDA-approved novel therapies,

  • 95 percent of EMA-authorized products, and

  • More than 200 studies across 73,000 sites and over 675,000 trial participants.

Employees across the organization contribute to shaping the future of clinical development and regulatory excellence.

Additional Information

The responsibilities listed are not exhaustive. Additional tasks may be assigned according to business needs. Equivalent qualifications or related experience may be considered. Syneos Health adheres to global employment laws, equal opportunity principles, and reasonable accommodation requirements.

Candidates who do not meet all requirements but demonstrate transferable skills are encouraged to apply. Applicants may also join the Syneos Health Talent Network for future opportunities.