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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 Hybrid Remote 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: Remote, India
Job ID: 25104034
Updated: Yesterday
Company: Syneos Health

About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions provider supporting clinical development, medical affairs, and commercial operations across global markets. With a presence in more than 110 countries and a workforce of 29,000 professionals, the organization delivers strategic, technology-driven solutions to accelerate the delivery of therapies.

The company operates with a patient- and customer-centered clinical development model, continually improving systems and processes to enhance efficiency and collaboration. Syneos Health is built on a culture of learning, inclusivity, and innovation, where diverse perspectives and continuous growth are highly valued.

Role Overview

The Regulatory Consultant / Senior Consultant – RIM/Veeva Business Analyst will support regulatory technology initiatives, business process optimization, and system governance for global regulatory operations. This remote role requires working in EST time shift to ensure effective collaboration with US-based teams and stakeholders.

Key Responsibilities

General Responsibilities

  • Apply system- and process-focused expertise with strong hands-on experience in RIM and Veeva platforms.

  • Demonstrate strong communication, stakeholder management, and analytical skills.

  • Participate in requirement gathering, system validation, and user acceptance testing.

  • Collaborate with cross-functional teams including Regulatory Operations, IT, and Process Development.

  • Operate effectively in a remote environment while aligning with EST time zone requirements.

Core Responsibilities

  • Act as a primary liaison between Regulatory Operations and IT/Tool Management teams.

  • Lead technology enablement and business process optimization related to RIM systems.

  • Gather, document, and maintain user requirements aligned with evolving business needs.

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

  • Support UAT activities through test script creation, execution oversight, and quality review.

  • Serve as a Subject Matter Expert (SME) for RIM systems, particularly Veeva Vault RIM.

  • Provide training, communication, and guidance to end users on system features and processes.

  • Manage RIM system enhancements in collaboration with IT and process development teams.

  • Coordinate with global teams to validate regulatory data, address system gaps, and support end-to-end workflows.

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

Required Qualifications & Experience

  • Master’s degree in Life Sciences, Pharmacy, Engineering, Information Technology, or related field.

  • Minimum 8+ years of professional experience, with strong exposure to regulatory systems and RIM platforms.

  • Proven hands-on experience in Veeva Vault RIM is essential.

  • Demonstrated expertise in requirement gathering, system validation, and UAT.

  • Ability to collaborate with global cross-functional teams while managing remote operations.

  • Strong communication, documentation, and stakeholder engagement skills.

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

  • Candidates with experience limited solely to regulatory publishing/submissions will not be considered.

Preferred Skills

  • Experience in global pharmaceutical, biotechnology, or contract research environments.

  • Strong business analysis, process mapping, and technology integration capabilities.

  • Ability to drive system enhancements and support enterprise-wide data integrity.

  • Detail-oriented mindset with a strong focus on accuracy and system compliance.

Why Join Syneos Health

  • Comprehensive career development and continuous learning programs.

  • Supportive leadership, technical training, and recognition programs.

  • A culture built on authenticity, inclusion, and global collaboration.

  • Opportunities to work with world-leading experts and advanced regulatory technologies.

  • Participation in impactful projects contributing to regulatory excellence and patient safety.

Global Impact

In the last five years, Syneos Health has supported:

  • 94 percent of all novel FDA-approved drugs,

  • 95 percent of EMA-authorized products, and

  • More than 200 clinical studies conducted at over 73,000 sites with 675,000+ trial participants.

Additional Information

Responsibilities may evolve based on business needs. Equivalent experience and transferable skills may be considered. The company is committed to equal opportunity practices, compliance with global employment laws, and the provision of reasonable accommodations where required.

Applicants who may not meet every listed qualification but possess relevant transferable skills are encouraged to apply. Candidates may also join the Syneos Health Talent Network to stay connected to future opportunities.