Job highlights

- Data architecture and meaning: Support consistent RQS data definitions and use
- ensure stakeholders document data meaning,master and metadata needs,security requirements,analytical use and governance for sustainable "data with meaning"
- Demonstrated experience as a Business Data Steward or comparable role with accountability for data standards,quality,ownership and issue resolution

Job Summary Your Role. As Senior RQS Data Specialist, you will help govern, improve and operate regulatory, quality and safety data and information. Working with the Veeva Vault RIM Data Lead, RQS Data Governance Lead and global stakeholders, you will turn regulatory, quality, safety and business needs into clear standards, data-quality controls, sustainable processes and fit-for-purpose information models.

Responsibilities

- Data governance and quality: Act as Business Data Steward and subject matter expert for enterprise regulatory data domains, including medicinal product, substance, organization, registration, manufacturing, submission and reference data.
- Define RQS data-management standards and principles (including FAIR and ALCOA+) as well as maintain data ownership and stewardship accountabilities; set data-quality objectives, entry and maintenance rules, controls, measures and remediation plans so data is accurate, complete, traceable and fit for business and regulatory use.
- Data operations: Coordinate people, processes and technology into a cohesive operating model covering roles, training, reporting, requirements capture, data-flow mapping, delivery mechanisms, lifecycle controls and resourcing.
- Ensure governance requirements are embedded in business processes, data products and supporting systems.
- Data architecture and meaning: Support consistent RQS data definitions and use; ensure stakeholders document data meaning, master and metadata needs, security requirements,



analytical use and governance for sustainable "data with meaning".
- Regulatory compliance and submissions: Support health-authority requirements for regulatory and medicinal-product information, applying xEVMPD, ISO IDMP and eCTD 4.0; contribute to data-focused discussions with health authorities, when applicable.
- Strategy and improvement: Support the RQS data strategy from vision through implementation and assess advanced technologies that reduce manual work, improve consistency and strengthen controls without compromising compliance.
- Leadership and collaboration: Provide pro-active (indirect) business leadership in cross-functional projects by owning the activities or coordinating RQS, RD, Healthcare, Life Science, DDIT, technology and data-management stakeholders to achieve the goals.
- Mentor and train junior colleagues as well as when applicable, oversee external CROs and service providers, resources and delivery in a matrix organization.

Requirements and Qualifications

- Who You Are: You combine regulatory information-management expertise with practical data-governance, process-improvement and stakeholder-leadership skills.
- You translate complex requirements into usable standards and controls, work constructively with uncertainty and take ownership for high-quality outcomes.
- Education: Bachelor's degree in scientific, regulatory information management, data management or technology discipline, or equivalent relevant experience.
- Experience: At least five years in a pharmaceutical, IT or service-provider environment,



including at least three years in Regulatory Affairs, Regulatory Operations or a related discipline with data-governance and master-data-management experience.
- Demonstrated experience as a Business Data Steward or comparable role with accountability for data standards, quality, ownership and issue resolution.
- Domain and systems: Proficient regulatory information-management skills, especially with relevant regulatory and data tools such as Veeva Vault RIM (mandatory), Microsoft Excel and SharePoint; familiarity with systems such as other Veeva Vaults, DMS and SAP is advantageous.
- Working knowledge of relevant regulatory data standards and ecosystems, including xEVMPD, ISO IDMP and EMA SPOR.
- Personal effectiveness: High attention to detail, independence, motivation and proactivity; results-oriented, pragmatic, meticulous and committed to high quality. Strong analytical capability with the judgement to prioritize data risks based on compliance, patient, operational and business impact.
- Influence and communication: Effective interpersonal, verbal and written communication skills with a collaborative mindset and a strong commitment to data integrity, regulatory compliance and continuous improvement. Demonstrated ability to make decisions and drive alignment across senior stakeholders in a global matrix organization. Able to develop creative, practical solutions while maintaining a service-oriented mindset.
- Language and culture: Fluent spoken and written English. Experience in a multicultural or multinational organization and demonstrated cultural awareness are highly desirable.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr RQS Data & Technology Manager (Bengaluru)
🏢 Merck
📍 Bengaluru