Lead, R&D Document Standards & Integrated Services

Main responsibilities

Strategic Leadership & Governance

Define and own the long-term strategy for all document standards, template governance, and submission-ready authoring across the global organization encompassing all

R&D Authoring functions

Standardize the preparation of documents intended for regulatory submission, ensuring alignment with regional and global Health Authority requirements across all submission types (e.g., NDA, MAA, IND, BLA, CTD)

Establish and lead a singular governance and quality control model for R&D encompassing document templates, including review cadence, approval workflows, and access controls to ensure quality at the source

Develop, version, and maintain Operational Procedures (OPEs) for template governance in alignment with GxP and regulatory standards

Drive continuous optimization of the template library to ensure efficiency, compliance, and alignment with evolving Health Authority requirements

Define and enforce clear template ownership, accountability, and maintenance responsibilities across various functions within R&D – including clinical, non-clinical, pharmacovigilance, regulatory and CMC.

Represent the Submission & Document Services Platform in governance committees and cross-functional initiatives, advocating for process optimization and standardization

Operational Excellence & Standardization

Lead the ongoing rationalization and harmonization of document templates across R&D ensuring a lean, well-governed, and consistently maintained library of documentation required for dossier submission.

Establish and sustain a single source of truth for formatting standards, ensuring consistent visual identity and style application across all R&D dossiers and authoring platforms

Lead cross-functional working groups — spanning Clinical, Nonclinical, Regulatory/Labeling, Quality, and PSPV — to drive workstream-specific alignment and continuous improvement

Partner with Digital in the management of style assets (including but not limited to .dot files and toolbar plug-ins) to ensure seamless author access and adherence to formatting standards

Create, maintain and monitor dashboards to track operational metrics and provide ongoing visibility to leadership on program health and performance

Develop and maintain standardized document preparation workflows specifically designed to meet submission requirements across multiple regulatory jurisdictions (e.g., FDA, EMA, PMDA, Health Canada, etc.)

Implement submission readiness checklists and quality review processes within Global Submissions management to ensure documents meet formatting, content, and structural requirements prior to dossier compilation

Technology Integration & Innovation

Partner with the eGSM lead, Digital and DDAI to evaluate, recommend, and implement tools and technologies that improve the efficiency and quality of document authoring and submission preparation, including AI-enabled and automation solutions

Ensure standardized templates and tooling serve as foundational enablers for the transition to GenAI-assisted authoring

Maintain awareness of the evolving regulatory technology landscape and proactively identify opportunities to modernize authoring and submission workflows

Partner with DDAI and Digital to integrate document standards capabilities into the broader R&D technology ecosystem

Evaluate and champion technology solutions that support end-to-end submission readiness, including document assembly, publishing, and electronic submission tools (e.g., eCTD)

Stakeholder Collaboration & Change Management

Strategically lead cross-functional stakeholders — including Clinical, Nonclinical, PSPV, M&S / CMC, and GRA — to ensure process alignment, integration, adoption of the new model

Build and maintain strong relationships across the R&D authoring community to drive sustained onboarding and adoption of standardized processes and tools

Design and deploy change management strategies and training programs that support authors through process and technology transitions

Develop communication strategies to ensure stakeholders are continuously informed about standards updates, available resources, and process improvements

Facilitate collaboration among global teams, including the Hyderabad Hub and Digital organization partners

Contribute to specification mapping, transition planning, and Business as Usual (BAU) requirements for process integration

Partner with Regulatory Operations and submission project managers to align document preparation timelines with submission planning milestones

About you

Education

Bachelor’s degree or equivalent degree in regulatory affairs, sciences, related areas of study and/or relevant experience. Master’s degree, preferred.

Experience

Minimum of 8 years of experience in pharmaceutical document management or regulatory operations, with demonstrated background in process optimization, continuous improvement methodologies, and cross-functional program leadership.

Soft, digital and technical skills

Proficiency with document management software and tools, such as electronic document management systems (EDMS), Adobe Acrobat, Microsoft Office Suite, Veeva Vault RIM

Understanding of eCTD submission standards required; understanding of regulatory Information Management systems is highly valued.

Excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization

Strong decision-making abilities with analytical approach to problem-solving.

Ability to manage simultaneous priorities and coordinate complex projects in a matrix environment

Demonstrated capacity to identify process inefficiencies and propose practical solutions

Strong decision-making abilities with an analytical approach to problem-solving

Strong analytical skills with the ability to translate data into actionable insights

Adaptability and flexibility to work in a fast-changing, innovation-driven environment

Ability to manage simultaneous priorities and coordinate complex, multi-workstream programs in a global matrix environment

Languages

English language proficiency required (verbal and written)