Job highlights

- Required Qualifications: . Master degree or equivalent level is strongly recommended (science or technology is preferred). At least 10 years experience in a (global) regulatory operations role or similar position associated with regulated processes and content in the pharma industry. At least 6 years experience managing people and / or teams in a cross-cultural / global setting.

Required Qualifications:

- Master degree or equivalent level is strongly recommended (science or technology is preferred)
- At least 10 years experience in a (global) regulatory operations role or similar position associated with regulated processes and content in the pharma industry
- At least 6 years experience managing people and/or teams in a cross-cultural / global setting
- Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
- Proven ability to define priorities and tasks across project teams, committees, etc. to attain group objectives
- Demonstrated leadership championing new processes and leading change management activities
- High integrity to maintain confidential and proprietary information
- Experience managing budgets for IT projects and external staffing needs
- Strong communication and collaboration skills
- Strong ability to communicate effectively in English, both writing and verbally in English speaking
- Participation in one or more industry groups, demonstrating knowledge of current and upcoming industry trends and initiatives

Preferred Qualifications:

- PhD degree, preferably in a science or technology field
- Experience with managing IT systems
- Proven expertise in document management, submission publishing, registration management, labeling, quality control and/or change control systems
- Experience in defining or interacting with information taxonomies, master data management or other structured data constructs

Working Environment

- This position is based in Global Capability Center (GCC) in India.
- To enable collaboration within the GCC 2-3 days per week on-site working is expected
- To enable collaboration with US stakeholders,



this role is expected to work 2-11 pm.
- This role will be a member of a brand or pipeline specific Value Team working following agile methodology to deliver impact

The position also requires establishing strong relationships with key vendors and with key personnel within the global Regulatory Affairs organization to champion the adoption of new systems and process improvements.

Purpose and Scope:

- The Lead is expected to have extensive experience and provide thought leadership in Data Governance and Compliance, as well as on how the regulatory systems, processes, and data interact and interface with other aspects of the Astellas information ecosystem.
- Responsibilities involve leading and enabling regulatory operations activities supporting all types of product offerings. This includes planning, preparation, submission, and tracking of submission packages, correspondence, and structured data to regulatory agencies. It also includes interpreting and ensuring adherence to internal and external procedures, regulations, and relevant submission and data standards.

Additionally, the role involves establishing unambiguous and reliable source data and systems and harmonizing tools and processes where possible. The Lead will monitor and influence the regulatory environment while identifying future business needs related to industry initiatives, agency requirements, and internal organizational changes. The position also requires establishing strong relationships with key vendors and with key personnel within the global Regulatory Affairs organization to champion the adoption of new systems and process improvements.

Responsibilities and Accountabilities:

Common Regulatory Operations Responsibilities





- Contributes to and executes against the RAPV strategy by creating 1-3 year plans for the RA system and process capabilities, aligning their group with the other RAPV Enablement groups, considering industry initiatives, Health Authority guidances, software vendor capabilities, corporate strategy, internal RA process improvements, system interactions with other functions and end user input.
- Ensures alignment of operating models and use of RA systems across all concerned RA functional departments during vendor/system selection activities, while preparing for current/major system implementations, and when evaluating ongoing process improvement opportunities in steady-state
- Is accountable for the measurement and evaluation of process effectiveness, vendor service delivery and standards with Key Performance Indicators, and introduces and maintains best practices leveraging methodologies such as Lean Six Sigma
- Manages and Leads staff and consultants as well as mentors junior staff members on regulatory processes, develops team through successful recruitment, performance management and by identifying professional growth opportunities for internal staff members
- Champions and sometimes leads cross-functional and/or industry initiatives including IT system implementations and process re-engineering projects, capable of representing all of Regulatory Operations
- Is accountable for resolving complex business problems with decision-making under time pressure, that impacts area of responsibility and Regulatory Operations as a whole
- Identifies the need for and ensures the assimilation of detailed interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact products and operations; prioritizes short- and long-term projects to implement relevant changes in system configurations and business processes to maximize efficiency and/or improve compliance

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.

📌 Team Lead, RAPV Data Governance and Compliance (Bengaluru)
🏢 ADP
📍 Bengaluru